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SEP 3 0 2008 510(k) Summary Fukuoka Dens hi Model FF Sonic UF-750XT Diagnostic Ultrasound System with option 3D imaging unit (UF-750XT-3DU) Summary of Safety and Effectiveness Prepared in accordance

How to fill out 510k summary - govfdaaccessdatawww

How to fill out 510k summary - govfdaaccessdatawww?

1. Access the FDA's website at govfdaaccessdatawww.
2. Locate the section for the 510k summary form.
3. Read the instructions provided by the FDA for filling out the form.
4. Gather all the relevant information and documents required for the 510k summary.
5. Begin filling out the form by entering the necessary details, such as the device name, description, intended use, and manufacturing information.
6. Provide information about the device's substantial equivalence to predicate devices, if applicable.
7. Include any necessary attachments, such as test reports or labeling examples.
8. Double-check all the information entered to ensure accuracy and completeness.
9. Save a copy of the completed form for your records.
10. Submit the filled-out form according to the instructions provided by the FDA.

Who needs 510k summary - govfdaaccessdatawww?

1. Medical device manufacturers who intend to market a new medical device in the United States may need to submit a 510k summary.
2. Regulatory affairs professionals who are responsible for preparing and submitting the necessary documentation to gain FDA clearance for new medical devices will need the 510k summary.
3. Other stakeholders, such as consultants or legal advisors, may also need to access the 510k summary to review and provide guidance on the submission process.

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What is 510k summary - govfdaaccessdatawww?

The 510(k) summary is a concise document that provides an overview of a medical device's intended use, technological characteristics, performance data, and similarities to predicate devices. It is submitted to the U.S. Food and Drug Administration (FDA) as part of the 510(k) premarket notification process.

Who is required to file 510k summary - govfdaaccessdatawww?

Any person or entity who wants to market a medical device in the United States that does not require a premarket approval must file a 510(k) summary with the FDA. This includes manufacturers, importers, and distributors of medical devices.

How to fill out 510k summary - govfdaaccessdatawww?

To fill out the 510(k) summary, the submitter needs to provide detailed information about the device, its intended use, technological characteristics, performance data, and any similarities to predicate devices. This information must be submitted electronically through the FDA's online portal, known as govfdaaccessdatawww.

What is the purpose of 510k summary - govfdaaccessdatawww?

The purpose of the 510(k) summary is to demonstrate to the FDA that a medical device is substantially equivalent to a predicate device already legally marketed in the United States. It provides a summary of the information needed to support the device's safety and effectiveness.

What information must be reported on 510k summary - govfdaaccessdatawww?

The 510(k) summary must include information about the medical device's intended use, technological characteristics, performance data, and any similarities to predicate devices. It should also outline the scientific rationale and testing conducted to demonstrate the device's safety and effectiveness.