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This document provides a comprehensive summary of the 510(k) submission for the BreathScan®PRO device, including its indications for use, description, safety and effectiveness data, as well as its equivalence to a predicate device. The BreathScan®PRO is designed to quantitatively detect the presence of alcohol in human breath as a screening instrument.
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What is breathscanpro 510k submission?
Breathscanpro 510k submission refers to the process of submitting documentation to the FDA to obtain clearance for a medical device that utilizes breath sample analysis. This submission demonstrates that the device is safe and effective for its intended use.
Who is required to file breathscanpro 510k submission?
Manufacturers and developers of the Breathscanpro medical device must file a 510k submission to the FDA before marketing their product in the United States.
How to fill out breathscanpro 510k submission?
To fill out the Breathscanpro 510k submission, manufacturers should complete the required forms provided by the FDA, including descriptions of the device, intended use, clinical data, labeling, and comparisons to a predicate device.
What is the purpose of breathscanpro 510k submission?
The purpose of the Breathscanpro 510k submission is to demonstrate to the FDA that the device is substantially equivalent to a legally marketed predicate device, ensuring safety and effectiveness for potential users.
What information must be reported on breathscanpro 510k submission?
The submission must include device description, intended use, labeling, performance testing data, and substantial equivalence information to a predicate device.
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