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510(k) Summary: K1230057211. Submitter:DE DCSwissray Medical AG Turbistrasse 25 27 CH6280 Rochford Switzerland Phone +4141914 12 12 Fax +41 41 914 12 13 Date Prepared: November 13, 2012, Contact:

How to fill out 510k summary k123005 suinsa

How to fill out 510k summary k123005 suinsa

1. Start by gathering all the necessary documentation and information required for the 510k summary form.
2. Fill out the basic details section of the form, such as the product name, manufacturer information, and FDA registration number.
3. Provide a brief description of the device and its intended use in the appropriate section.
4. Include any references to published standards or guidance documents that were followed during the development of the device.
5. Describe the testing procedures and results, including any performance data or safety information.
6. If applicable, provide information on any predicate devices that were used as a basis for substantial equivalence.
7. Include any labeling or packaging information, such as instructions for use or warnings.
8. Review the completed form for accuracy and completeness before submitting it to the FDA.
9. Submit the 510k summary form along with any supporting documentation to the FDA for review and approval.

Who needs 510k summary k123005 suinsa?

1. Anyone seeking to obtain FDA clearance for a new medical device that is not exempt from premarket notification requirements needs a 510k summary form.
2. The specific product mentioned in the question, k123005 suinsa, would require a 510k summary form for FDA clearance.

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What is 510k summary k123005 suinsa?

The 510k summary k123005 suinsa is a summary of a premarket notification submission to the FDA for a medical device.

Who is required to file 510k summary k123005 suinsa?

The manufacturer or distributor of the medical device is required to file the 510k summary k123005 suinsa with the FDA.

How to fill out 510k summary k123005 suinsa?

To fill out the 510k summary k123005 suinsa, the manufacturer or distributor must provide detailed information about the medical device, its intended use, performance data, and comparison to similar devices on the market.

What is the purpose of 510k summary k123005 suinsa?

The purpose of the 510k summary k123005 suinsa is to demonstrate to the FDA that the medical device is substantially equivalent to a previously cleared device and is safe and effective for its intended use.

What information must be reported on 510k summary k123005 suinsa?

The 510k summary k123005 suinsa must include information on device description, indications for use, device performance data, materials and design specifications, labeling, and any special controls or post-market surveillance requirements.