FDA 510(k) Application Details - K200948

Device Classification Name	More FDA Info for this Device
510(K) Number	K200948
Device Name	Fitbit ECG App
Applicant	Fitbit, Inc. 199 Fremont Street San Francisco, CA 94105 US Other 510(k) Applications for this Company
Contact	Shruti Rajagopalan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/08/2020
Decision Date	09/11/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review