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Section 6510(k) Summary FEB 0 4t 2013K120804 Page 1 of 3 510(k) Summary This 510(k) summary information is being submitted in accordance with the requirements of SODA 1990 and 21 CFR 807.92. APPLICANT:Dianna

How to fill out this summary of 510k

How to fill out this summary of 510k

1. To fill out the summary of 510k, follow these steps:
2. Begin by providing the device information, including the device name, type, and identification number.
3. Include a brief description of the device's intended use and indication for use.
4. Provide a summary of the technological characteristics of the device.
5. Include any substantial modifications made to the device since its last submission.
6. Summarize the results of relevant non-clinical performance testing and demonstrate the device's substantial equivalence to predicate devices.
7. Provide a summary of the clinical data, if applicable, and highlight any significant risks or adverse events.
8. Include a detailed labeling summary, including instructions for use, warnings, and precautions.
9. If there have been any recalls or corrective actions related to the device, provide a summary of these incidents.
10. Conclude the summary with a declaration of conformity and contact information for the submitter.
11. Review and verify the information provided before submitting the completed summary of 510k.

Who needs this summary of 510k?

1. The summary of 510k is needed by medical device manufacturers and importers who are seeking FDA clearance to market a new medical device or make a substantial modification to an existing device.
2. Additionally, regulatory professionals, quality assurance personnel, and consultants involved in the FDA submission process may also require the summary of 510k to ensure compliance with regulatory requirements.

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What is this summary of 510k?

This summary of 510k is a brief overview of a premarket notification submission that provides information about a medical device.

Who is required to file this summary of 510k?

Manufacturers of medical devices are required to file this summary of 510k with the Food and Drug Administration (FDA).

How to fill out this summary of 510k?

The summary of 510k can be filled out by including information such as device description, intended use, performance data, and comparisons to similar devices already on the market.

What is the purpose of this summary of 510k?

The purpose of this summary of 510k is to demonstrate that a medical device is substantially equivalent to a legally marketed device and does not pose a significant risk to public health.

What information must be reported on this summary of 510k?

The information that must be reported on this summary of 510k includes details about the device, its intended use, performance data, and any relevant comparisons to similar devices.