FDA 510(k) Application Details - K083630

Device Classification Name	Transmitters And Receivers, Electrocardiograph, Telephone   More FDA Info for this Device
510(K) Number	K083630
Device Name	Transmitters And Receivers, Electrocardiograph, Telephone
Applicant	TELOVITAL GMBH TELEMEDIZIN 901 KING ST., SUITE 200 ALEXANDRIA, VA 22314 US Other 510(k) Applications for this Company
Contact	CHERITA JAMES 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	12/08/2008
Decision Date	04/23/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review