FDA 510(k) Application Details - K212662

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K212662
Device Name	Computer, Diagnostic, Programmable
Applicant	AliveCor, Inc. 189 N Bernardo Ave., Suite 100 Mountain View, CA 94043 US Other 510(k) Applications for this Company
Contact	Susan Noriega Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2021
Decision Date	04/26/2022
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