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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k173327 B. Purpose for Submission: New device C. Measured: Measurement of the
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What is 510k substantial equivalence determination?
510k substantial equivalence determination is a process by which medical devices are compared to predicate devices to demonstrate that they are substantially equivalent in terms of safety and effectiveness.
Who is required to file 510k substantial equivalence determination?
Manufacturers of medical devices that do not require premarket approval are required to file 510k substantial equivalence determination.
How to fill out 510k substantial equivalence determination?
To fill out 510k substantial equivalence determination, manufacturers need to provide detailed information about the device, its intended use, and comparison to predicate devices.
What is the purpose of 510k substantial equivalence determination?
The purpose of 510k substantial equivalence determination is to demonstrate that a new medical device is as safe and effective as an existing device with the same intended use.
What information must be reported on 510k substantial equivalence determination?
Information such as device description, intended use, materials, design, performance data, and testing results must be reported on 510k substantial equivalence determination.
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