FDA 510(k) Application Details - K974510

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K974510
Device Name	Detector And Alarm, Arrhythmia
Applicant	MENNEN MEDICAL, INC. KIRYAT WEIZMANN SCIENCE PARK P.O. BOX 102 REHOVOT 76100 IL Other 510(k) Applications for this Company
Contact	KENNETH RAICHMAN Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	DSI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/01/1997
Decision Date	04/14/1998
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