FDA 510(k) Application Details - K213971

Device Classification Name	More FDA Info for this Device
510(K) Number	K213971
Device Name	Atrial Fibrillation History Feature
Applicant	Apple Inc. 1 Apple Park Way Cupertino, CA 95014 US Other 510(k) Applications for this Company
Contact	Luke Olson 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	12/20/2021
Decision Date	06/03/2022
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