Get the free 510(k) K132957

Product code GWJ Device Class Class 11 FDA CFR Section FDA 21CFR 882. 1900 Equivalent legally marketed devices Predicate Product Name 510 k Number Devices Echo-Screen T TA TD TDA TC K013977 Stimulator Auditory Evoked Response DevcePrdut Code Manuactuer Name Type 1077 AccuScreen K122067 GWJ Fiseher-Zoth Audiologic Systems OWJ ON Otometrics Description of the Device The device is identical to our own device described in K122067. Fda.2ov/AboutFDA/CentersOtfices/CDRH/CDRHOmeies/ucmn II 5809. htm...

How to fill out 510k k132957

How to fill out 510k k132957

1. Start by gathering all the necessary documents and information required for filling out the 510k form for the medical device with reference number K132957.
2. Read the instructions and guidelines provided by the regulatory authority thoroughly before filling out the form.
3. Begin by filling out the basic information section, including the company name, address, and contact details.
4. Provide detailed information about the medical device, including its intended use, design specifications, and components.
5. Include any existing relevant certifications or clearances obtained for the device.
6. Provide a comprehensive summary of any clinical studies conducted on the device and their results.
7. Describe any potential risks associated with the device and include a detailed risk management plan.
8. Include information on the labeling and packaging of the device.
9. If applicable, provide information on any software or firmware used in conjunction with the device.
10. Fill out the sections related to sterilization, biocompatibility, and any other relevant testing conducted.
11. Review the completed form for accuracy and completeness before submitting it to the regulatory authority.
12. Ensure all necessary supporting documents are included with the submission.
13. Submit the filled-out 510k form along with the required fee to the designated regulatory authority.
14. Track the progress of the submission and respond promptly to any requests for additional information or clarifications.
15. Await approval or feedback from the regulatory authority regarding the 510k submission.

Who needs 510k k132957?

1. Medical device manufacturers who intend to market a device similar to the one with reference number K132957 might need to obtain a 510k clearance.
2. Healthcare institutions or facilities that plan to use the medical device with reference number K132957 in their practice may require information about its safety and effectiveness through the 510k submission.
3. Regulatory bodies overseeing medical device approvals and clearances may need the 510k submission for evaluating the device's compliance with applicable regulations.
4. Insurance companies providing coverage for medical devices may require the 510k clearance as a prerequisite for reimbursement or coverage.

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What is 510k k132957?

The 510k k132957 is a premarket submission made to the FDA to demonstrate that a medical device is safe and effective.

Who is required to file 510k k132957?

Manufacturers of medical devices are required to file a 510k submission with the FDA if they want to market a new device or a modified device.

How to fill out 510k k132957?

To fill out a 510k submission, manufacturers need to provide detailed information about the device, its intended use, and any clinical testing that has been conducted.

What is the purpose of 510k k132957?

The purpose of a 510k submission is to demonstrate that a new or modified medical device is substantially equivalent to a device that is already legally marketed.

What information must be reported on 510k k132957?

Information that must be reported on a 510k submission includes device descriptions, indications for use, technological characteristics, and performance data.