Get the free 510(k) Summary Date of Submission: November 28, 2012 ... - FDA
Show details
MAR 07 2013 5.0510(k) SummaryX1 23654,y, j.p 1 46 “:The proposed device, Soundcheck Ill is substantially equivalent to its predicate, Soundcheck v2.2 (K080168) by virtue of a common indication for
We are not affiliated with any brand or entity on this form
Get, Create, Make and Sign 510k summary date of
Edit your 510k summary date of 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 summary date of form via URL. You can also download, print, or export forms to your preferred cloud storage service.
How to edit 510k summary date of online
Follow the guidelines 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 yet.
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 summary date of. Add and replace text, insert new objects, rearrange pages, add watermarks and page numbers, and more. Click Done when you are finished editing and go to the Documents tab to merge, split, lock or unlock the file.
4
Save your file. Select it in the list of your records. Then, move the cursor to the right toolbar and choose one of the available exporting methods: save it in multiple formats, download it as a PDF, send it by email, or store it in the cloud.
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 summary date of
How to fill out 510k summary date of
01
To fill out the 510k summary date, follow these steps:
02
Start by retrieving the necessary information about the medical device for which you are creating the 510k summary.
03
Begin the summary by providing a brief overview of the device, including its intended use, technological characteristics, and indications for use.
04
Include any relevant predicate devices that are similar to the device being submitted for 510k clearance.
05
Specify the differences between the device and its predicate(s), highlighting any new or modified features.
06
Summarize the results of any performance testing or clinical studies conducted to validate the safety and effectiveness of the device.
07
Include a section on labeling, highlighting any changes from the predicate device's labeling.
08
Provide a summary of any adverse events or device malfunctions associated with the device, if applicable.
09
Include a summary of any post-market surveillance data or studies.
10
Finally, review and revise the summary to ensure accuracy and completeness, considering all relevant regulatory requirements and guidance documents.
11
Once you have completed the summary, submit it along with the rest of the 510k submission package to the appropriate regulatory authority for review.
Who needs 510k summary date of?
01
Anyone seeking to obtain 510k clearance for a medical device needs the 510k summary date. This includes manufacturers, importers, and distributors of medical devices.
02
Regulatory authorities use the 510k summary date to evaluate the safety and effectiveness of the device in question and determine whether it can be cleared for marketing and distribution in the respective country or region.
03
Healthcare professionals and patients may also benefit from reviewing the 510k summary date to gain a better understanding of the device and its intended use before making informed decisions about its use.
Fill
form
: Try Risk Free
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.
Can I sign the 510k summary date of electronically in Chrome?
Yes. By adding the solution to your Chrome browser, you may use pdfFiller to eSign documents while also enjoying all of the PDF editor's capabilities in one spot. Create a legally enforceable eSignature by sketching, typing, or uploading a photo of your handwritten signature using the extension. Whatever option you select, you'll be able to eSign your 510k summary date of in seconds.
Can I edit 510k summary date of on an iOS device?
Use the pdfFiller mobile app to create, edit, and share 510k summary date of from your iOS device. Install it from the Apple Store in seconds. You can benefit from a free trial and choose a subscription that suits your needs.
How do I fill out 510k summary date of on an Android device?
Complete 510k summary date of and other documents on your Android device with the pdfFiller app. The software allows you to modify information, eSign, annotate, and share files. You may view your papers from anywhere with an internet connection.
What is 510k summary date of?
The 510k summary date is a summary of premarket notification submitted to the FDA for new medical devices.
Who is required to file 510k summary date of?
Manufacturers of medical devices are required to file 510k summary date.
How to fill out 510k summary date of?
To fill out 510k summary date, manufacturers need to provide a summary of the safety and effectiveness of the medical device.
What is the purpose of 510k summary date of?
The purpose of 510k summary date is to demonstrate that the new medical device is substantially equivalent to a legally marketed device.
What information must be reported on 510k summary date of?
Information such as device description, intended use, comparison to a predicate device, and performance data must be reported on 510k summary date.
Fill out your 510k summary date of 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 Summary Date Of 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.
