• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
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FDA 510(k) K200948, Fitbit ECG App, by Fitbit, Inc.

FDA 510(k) K200948, Fitbit ECG App, by Fitbit, Inc.

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510(K) Number: K200948
Device Name: Fitbit ECG App
Manufacturer: Fitbit, Inc.
Device Classification Name: Electrocardiograph Software For Over-The-Counter Use
Regulation Number: 870.2345
Classification Product Code: QDA
Date Received: 04/08/2020
Decision Date: 09/11/2020
Regulation Medical Specialty: Cardiovascular

313 pages (1,613 of 1,928 pages are fully redacted)
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