Get the free 1k*413-73A 510(k) S ummary- iPlan

1k×41373A Jr BRAINLAB510O(k) Summary PlanMAY510(k) Summary iPlan1. Manufacturer Brain lab AG Address: Kapellenstrasse 12 85622 Feldkirch Germany Phone: +49 89 99 15 68 0 Fax: +49 89 99 15 68 33 Contact

How to fill out 1k413-73a 510k s ummary

How to fill out 1k413-73a 510k s ummary

1. To fill out the 1K413-73A 510k summary form, follow these steps:
2. Start by entering the relevant company information, such as the company name, address, and contact details.
3. Provide a brief summary of the device for which the 510k submission is being made. Include details about its intended use, indications for use, and technological characteristics.
4. Describe the device's performance characteristics, including its design features, materials used, and any unique specifications.
5. Include information about any non-clinical testing conducted, such as bench testing or animal studies.
6. Discuss the clinical testing conducted, if applicable, and provide details about the study design, patient population, endpoints, and results.
7. Summarize any adverse events or safety concerns encountered during the testing phase.
8. Provide a comparison to legally marketed devices that demonstrate substantial equivalence.
9. Include a summary of the device labeling, including its intended use, warnings, and precautions.
10. Finally, review the completed form for accuracy and completeness before submission.
11. Remember to consult the FDA guidelines and regulations for comprehensive instructions on filling out the 1K413-73A 510k summary form.

Who needs 1k413-73a 510k s ummary?

1. Any company or manufacturer seeking to obtain FDA clearance or approval for a medical device needs to submit a 1K413-73A 510k summary.
2. This form is required when demonstrating substantial equivalence to a legally marketed device, as per the FDA regulations.
3. Companies involved in the development, manufacturing, or distribution of medical devices must comply with these requirements.
4. It is important to ensure that the device meets the necessary safety and effectiveness standards before marketing it in the United States.

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What is 1k413-73a 510k summary?

1k413-73a 510k summary is a summary of a premarket notification submission made to the FDA for a medical device.

Who is required to file 1k413-73a 510k summary?

Manufacturers or sponsors of medical devices who are seeking FDA approval to market their device in the US are required to file a 510k summary.

How to fill out 1k413-73a 510k summary?

To fill out a 510k summary, the manufacturer or sponsor needs to provide detailed information on the safety and effectiveness of the medical device, as well as any similar devices already on the market.

What is the purpose of 1k413-73a 510k summary?

The purpose of a 510k summary is to demonstrate to the FDA that the medical device is substantially equivalent to a device already on the market and is therefore safe and effective for use.

What information must be reported on 1k413-73a 510k summary?

The 510k summary must include information on the device description, intended use, technological characteristics, testing data, and comparisons to similar devices.