FDA 510(k) Application Details - K212372

Device Classification Name	More FDA Info for this Device
510(K) Number	K212372
Device Name	Fitbit Irregular Rhythm Notifications
Applicant	Fitbit Inc 199 Fremont Street 14th Floor San Francisco, CA 94105 US Other 510(k) Applications for this Company
Contact	Randy Parry Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/30/2021
Decision Date	04/08/2022
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