FDA 510(k), K200948, Fitbit ECG App

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)