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DEPARTMENT OF HEALTH & HUMAN SERVICESPublic Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66G609 Silver Spring, MD 209930002Sonoscape Company Limited

How to fill out 004510k summary

How to fill out 004510k summary

1. To fill out the 004510k summary, follow these steps:
2. Start by gathering all the necessary information, such as the product name, manufacturer details, and intended use of the device.
3. Identify the appropriate device classification and the relevant product code.
4. Provide a brief description of the device and its intended use.
5. Include any predicate devices that are similar to the one being submitted for the 004510k.
6. List any applicable standards and testing methods that were used to evaluate the device.
7. Include information about the performance characteristics of the device, as well as any known risks and safety measures.
8. Document any clinical studies or validations that have been conducted on the device.
9. Provide a detailed summary of the test results and performance data.
10. Include any labeling or instructions for use that will accompany the device.
11. Double-check all the information for accuracy and completeness before submitting the 004510k summary.

Who needs 004510k summary?

1. Medical device manufacturers and distributors who intend to market a new device in the United States need to submit a 004510k summary.
2. This summary is required by the Food and Drug Administration (FDA) to demonstrate that the device is substantially equivalent to a legally marketed device and does not pose any significant risks to public health.
3. In addition, healthcare facilities and professionals who plan to use or prescribe the device may also find the 004510k summary helpful in understanding its intended use, performance characteristics, and safety measures.

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What is 004510k summary?

004510k summary is a summary of pre-market notification submission for medical devices.

Who is required to file 004510k summary?

Manufacturers of medical devices who are seeking marketing clearance in the United States are required to file 004510k summary.

How to fill out 004510k summary?

To fill out 004510k summary, manufacturers need to provide detailed information about the safety and effectiveness of their medical device.

What is the purpose of 004510k summary?

The purpose of 004510k summary is to demonstrate that a medical device is substantially equivalent to another device that is already legally marketed in the United States.

What information must be reported on 004510k summary?

Information such as device description, intended use, technological characteristics, performance testing, and labeling must be reported on 004510k summary.