FDA 510(k) Application Details - K963904

Device Classification Name	Transmitters And Receivers, Electrocardiograph, Telephone   More FDA Info for this Device
510(K) Number	K963904
Device Name	Transmitters And Receivers, Electrocardiograph, Telephone
Applicant	HEART ALERT, INC. 6140 CENTRAL CHURCH RD. DOUGLASVILLE, GA 30135 US Other 510(k) Applications for this Company
Contact	CATHY FAUST 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	09/30/1996
Decision Date	05/15/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review