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JN121 510(K) SUMMARY This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SODA 1990 and 21 CFR 807.92. The assigned 510O(K) number
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What is this summary of 510k?
This summary of 510k is a brief overview of a medical device submission to the FDA for premarket notification.
Who is required to file this summary of 510k?
Manufacturers of medical devices seeking FDA approval are required to file this summary of 510k.
How to fill out this summary of 510k?
The summary of 510k must be filled out accurately and completely, providing all necessary information about the medical device submission.
What is the purpose of this summary of 510k?
The purpose of the summary of 510k is to provide the FDA with a concise overview of the medical device submission to facilitate the review process.
What information must be reported on this summary of 510k?
The summary of 510k must include information about the device, its intended use, performance data, and any similarities to other devices on the market.
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