Get the free K140845 510(K) Summary

K140845 510 K Summary 510 k SUMMARY JUL 18 2014 Otoharmonics 0 Levo 9 System Submitter s Name Address Telephone Number Contact Person and Date Prepared Otoharmonics Corp 411 SW 6th Ave Portland Oregon 97204 Phone 503. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health CDRH Signat urn Ting Zhang -S 2014. In addition the Levo System transmits data wirelessly between the devices whereas the predicate device utilizes a USB cord. 3400 Product Code KLW Class 11 Predicate...

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How to fill out k140845 510k summary

1. Read the instructions provided in the K140845 510k summary form.
2. Gather all the necessary information and documents required to fill out the form.
3. Start by entering the basic information such as device name, manufacturer details, and 510k number.
4. Provide a detailed description of the device and its intended use in the appropriate section.
5. Include any clinical data or test results that support the safety and effectiveness of the device.
6. Ensure that all the required sections are completed accurately and comprehensively.
7. Review the completed form for any errors or missing information.
8. Submit the filled-out K140845 510k summary form according to the specified submission guidelines.

Who needs k140845 510k summary?

1. Manufacturers of medical devices seeking FDA clearance for their products.
2. Regulatory affairs professionals responsible for preparing 510k submissions.
3. Medical device consultants assisting companies in the regulatory process.
4. FDA reviewers and evaluators assessing the safety and effectiveness of the device.
5. Anyone involved in the research, development, or commercialization of medical devices subject to FDA clearance.

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What is k140845 510k summary?

K140845 510(k) summary is a concise document that summarizes the information submitted in a premarket notification submission for a medical device.

Who is required to file k140845 510k summary?

Medical device manufacturers are required to file k140845 510(k) summary with the FDA for certain types of medical devices.

How to fill out k140845 510k summary?

To fill out k140845 510(k) summary, manufacturers must provide information about the device, its intended use, technological characteristics, and performance data.

What is the purpose of k140845 510k summary?

The purpose of k140845 510(k) summary is to demonstrate that a new medical device is substantially equivalent to a predicate device and therefore can be marketed in the US.

What information must be reported on k140845 510k summary?

Information such as device description, indications for use, technological characteristics, performance data, and labeling must be reported on k140845 510(k) summary.