Get the free 510(k) Submission Report for Contec Pocket Fetal Doppler - accessdata fda
Show details
This document is a 510(k) submission report submitted to the FDA for the Contec Pocket Fetal Doppler, detailing the device's intended use, description, and equivalence to a predicate device.
We are not affiliated with any brand or entity on this form
Get, Create, Make and Sign 510k submission report for
Edit your 510k submission report for form online
Type text, complete fillable fields, insert images, highlight or blackout data for discretion, add comments, and more.
Add your legally-binding signature
Draw or type your signature, upload a signature image, or capture it with your digital camera.
Share your form instantly
Email, fax, or share your 510k submission report for form via URL. You can also download, print, or export forms to your preferred cloud storage service.
Editing 510k submission report for online
Follow the steps below to take advantage of the professional PDF editor:
1
Log in to account. Click on Start Free Trial and register a profile if you don't have one.
2
Prepare a file. Use the Add New button. Then upload your file to the system from your device, importing it from internal mail, the cloud, or by adding its URL.
3
Edit 510k submission report for. Text may be added and replaced, new objects can be included, pages can be rearranged, watermarks and page numbers can be added, and so on. When you're done editing, click Done and then go to the Documents tab to combine, divide, lock, or unlock the file.
4
Get your file. When you find your file in the docs list, click on its name and choose how you want to save it. To get the PDF, you can save it, send an email with it, or move it to the cloud.
With pdfFiller, dealing with documents is always straightforward.
Uncompromising security for your PDF editing and eSignature needs
Your private information is safe with pdfFiller. We employ end-to-end encryption, secure cloud storage, and advanced access control to protect your documents and maintain regulatory compliance.
How to fill out 510k submission report for
How to fill out 510(k) Submission Report for Contec Pocket Fetal Doppler
01
Gather necessary product information including device description, intended use, and indications for use.
02
Compile information on the predicate device(s) to which you are comparing the Contec Pocket Fetal Doppler.
03
Include performance testing data, such as safety and effectiveness of the device.
04
Prepare labeling materials that include instructions for use, contraindications, warnings, and precautions.
05
Fill out the 510(k) Submission Form, ensuring all required sections are complete and accurate.
06
Prepare a cover letter summarizing the submission and the purpose of the 510(k).
07
Submit the completed 510(k) package electronically or via mail to the FDA.
08
Monitor the submission status and respond to any requests for additional information from the FDA.
Who needs 510(k) Submission Report for Contec Pocket Fetal Doppler?
01
Manufacturers of the Contec Pocket Fetal Doppler must submit a 510(k) Submission Report to the FDA.
02
Healthcare providers or entities looking to market or sell the Contec Pocket Fetal Doppler in the U.S. must ensure compliance through the 510(k) process.
Fill
form
: Try Risk Free
People Also Ask about
What does a Doppler scan show in pregnancy?
Doppler ultrasound uses sound waves to detect the movement of blood in vessels. It is used in pregnancy to study blood circulation in the baby, and placenta. Using it in high‐risk pregnancies, where there is concern about the baby's condition, shows benefits.
What is a pocket fetal Doppler?
The normal fetal heart rate ranges between 110 and 160 beats per minute with a base- line variability of 5 beats per minute. On the labour ward, the fetal heart rate is usually measured over time with an electronic fetal monitor, which gives a paper trace, and is interpreted by experienced midwives and obstetricians.
What is fetal Doppler scan report?
Fetal Doppler: A fetal Doppler is a test that uses sound waves to check your baby's heartbeat. It's a type of ultrasound that uses a handheld device to detect changes in movement that are translated as sound. Most women first hear their baby's heartbeat during a routine checkup that uses the fetal Doppler.
What are the numbers on fetal Doppler?
Fetalplus at-home fetal doppler is designed to track your baby's heartbeat from the first trimester, as early as 9 weeks. When choosing a fetal doppler, it is important to choose a quality product with the highest standard of safety and accuracy. The FetalPlus At-home Fetal Doppler has obtained FDA clearance.
How do you read a Doppler ultrasound report?
In Doppler ultrasounds, red and blue colors have specific meanings. Blood flowing toward the transducer (arterial blood flow) appears in red, whereas blood flowing away from the probe (venous blood flow) appears in blue.
What is a normal fetal Doppler reading?
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change as your baby responds to conditions in your .
What is a normal result of a Doppler study?
If your Doppler ultrasound results are normal, it means that the blood vessels that were checked looked healthy. They have no narrowing or blood clots. The blood flow was normal. If your results aren't normal, the meaning will depend on what area of your body was tested and the type of Doppler ultrasound that you had.
For pdfFiller’s FAQs
Below is a list of the most common customer questions. If you can’t find an answer to your question, please don’t hesitate to reach out to us.
What is 510(k) Submission Report for Contec Pocket Fetal Doppler?
The 510(k) Submission Report for Contec Pocket Fetal Doppler is a premarket notification submitted to the FDA to demonstrate that the device is safe and effective and is substantially equivalent to a legally marketed device.
Who is required to file 510(k) Submission Report for Contec Pocket Fetal Doppler?
Manufacturers or importers of the Contec Pocket Fetal Doppler who wish to market the device in the United States must file the 510(k) Submission Report.
How to fill out 510(k) Submission Report for Contec Pocket Fetal Doppler?
To fill out a 510(k) Submission Report, manufacturers need to provide details such as device description, intended use, labeling, performance testing, and a comparison to a predicate device.
What is the purpose of 510(k) Submission Report for Contec Pocket Fetal Doppler?
The purpose of the 510(k) Submission Report is to obtain FDA clearance for the market entry of the device, assuring that it meets regulatory requirements for safety and effectiveness.
What information must be reported on 510(k) Submission Report for Contec Pocket Fetal Doppler?
The 510(k) Submission Report must include information such as the device name, manufacturer details, intended use, technological characteristics, performance data, and labeling including instructions for use.
Fill out your 510k submission report for online with pdfFiller!
pdfFiller is an end-to-end solution for managing, creating, and editing documents and forms in the cloud. Save time and hassle by preparing your tax forms online.
510k Submission Report For is not the form you're looking for?Search for another form here.
Relevant keywords
Related Forms
If you believe that this page should be taken down, please follow our DMCA take down process
here
.
This form may include fields for payment information. Data entered in these fields is not covered by PCI DSS compliance.
