FDA 510(k) Application Details - K212516

Device Classification Name	More FDA Info for this Device
510(K) Number	K212516
Device Name	IRNF App
Applicant	Apple Inc. 1 Apple Park Way Cupertino, CA 95014 US Other 510(k) Applications for this Company
Contact	Dachan Kwon 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	08/10/2021
Decision Date	10/22/2021
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