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12a57 g FEB 2 5 2013 510(k) Summary This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92. Purpose of Submission: Vital Images, Inc. hereby submits this traditional
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What is feb 2 5 510k?
feb 2 5 510k refers to a pre-market notification submission made to the FDA to demonstrate that a medical device is substantially equivalent to a predicate device.
Who is required to file feb 2 5 510k?
Manufacturers of medical devices are usually required to file a feb 2 5 510k submission with the FDA.
How to fill out feb 2 5 510k?
To fill out a feb 2 5 510k submission, the manufacturer must provide detailed information about the medical device, its intended use, and comparisons to similar devices on the market.
What is the purpose of feb 2 5 510k?
The purpose of a feb 2 5 510k submission is to demonstrate that a medical device is safe and effective for its intended use by showing substantial equivalence to a legally marketed device.
What information must be reported on feb 2 5 510k?
A feb 2 5 510k submission must include information about the device description, indications for use, performance data, and comparison to a predicate device.
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