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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION MEMORANDUM. 510(k) Number:
K170960
B. Purpose for Submission:
New device
C. Measured:
International Normalized Ratio (INR)
D. Type of Test:
Electrochemical
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How to fill out 510k substantial equivalence determination
How to fill out 510k substantial equivalence determination
01
To fill out a 510k substantial equivalence determination, follow these steps:
02
Start by gathering all necessary information and documentation about your medical device.
03
Review the FDA guidance documents and regulations related to substantial equivalence determination.
04
Complete the necessary forms, such as Form FDA 3514, providing all required information about your device.
05
Prepare a detailed summary of the similarities and differences between your device and the predicate device.
06
Include any additional testing or data that supports the substantial equivalence of your device.
07
Submit the filled-out form, along with all supporting documentation, to the FDA for review.
08
Follow up with the FDA as needed to address any questions or concerns they may have.
09
Await a decision from the FDA regarding the substantial equivalence determination of your device.
Who needs 510k substantial equivalence determination?
01
Manufacturers of medical devices that are intended to be marketed in the United States need a 510k substantial equivalence determination.
02
Any company or individual who wants to market a new medical device or a modified version of an existing device must go through the 510k process.
03
It is necessary to obtain a substantial equivalence determination to demonstrate that the new device or modification is as safe and effective as the predicate device in order to gain FDA approval for marketing.
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What is 510k substantial equivalence determination?
The 510k substantial equivalence determination is a premarket submission made to the FDA to demonstrate that a new medical device is substantially equivalent to a predicate device that is already legally marketed.
Who is required to file 510k substantial equivalence determination?
Any manufacturer intending to market a new medical device in the United States is required to file a 510k substantial equivalence determination.
How to fill out 510k substantial equivalence determination?
To fill out a 510k substantial equivalence determination, the manufacturer must provide detailed information about the new device, comparison with the predicate device, and any additional testing or data to support the claim of substantial equivalence.
What is the purpose of 510k substantial equivalence determination?
The purpose of the 510k substantial equivalence determination is to demonstrate that the new device is as safe and effective as the predicate device, thus allowing it to be cleared for marketing in the United States.
What information must be reported on 510k substantial equivalence determination?
The 510k substantial equivalence determination must include detailed descriptions of the new device, comparison with the predicate device, performance data, and any labeling information.
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