FDA 510(k) Application Details - DEN180044

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN180044
Device Name	ECG App
Applicant	Apple Inc c/o Biologics Consulting Group 400 N Washington St., Suite 100 Alexandria, VA 22314 US Other 510(k) Applications for this Company
Contact	Donna-Bea Tillman 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	08/14/2018
Decision Date	09/11/2018
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review