FDA 510(k) Application Details - K964836

Device Classification Name	Transmitters And Receivers, Electrocardiograph, Telephone   More FDA Info for this Device
510(K) Number	K964836
Device Name	Transmitters And Receivers, Electrocardiograph, Telephone
Applicant	CARD GUARD SCIENTIFIC SURVIVAL, LTD. 12 HACHOMA ST. RISHON LE-ZION 75655 IL Other 510(k) Applications for this Company
Contact	LEONID TRACHTENBERG 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	11/29/1996
Decision Date	07/28/1997
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