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Wed.Dec 01, 2021

Unpacking Averages: Popular Ways to Combine Device Functionality

Health Law Advisor

DECEMBER 1, 2021

We could similarly produce a chart for any therapeutic device category. And instead of relationships, we are going to look at when device functionalities (i.e., product codes) are used together in a marketed device as evidenced by a 510(k) submission. In the chart below, we limit ourselves to the example of cardiology devices.

FDA

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