FDA 510(k) Application Details - K121628

Device Classification Name	Transmitters And Receivers, Electrocardiograph, Telephone   More FDA Info for this Device
510(K) Number	K121628
Device Name	Transmitters And Receivers, Electrocardiograph, Telephone
Applicant	EPI MOBILE HEALTH SOLUTIONS (S) PTE LTD 1200 19TH STREET, NW WASHINGTON, DC 20032 US Other 510(k) Applications for this Company
Contact	KARL M NOBERT Other 510(k) Applications for this Contact
Regulation Number	870.2920   More FDA Info for this Regulation Number
Classification Product Code	DXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/04/2012
Decision Date	06/25/2013
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