FDA 510(k) Application Details - K974792

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K974792
Device Name	Detector And Alarm, Arrhythmia
Applicant	DATEX-ENGSTROM, INC. 2 HIGHWOOD DR. TEWKSBURY, MA 01876 US Other 510(k) Applications for this Company
Contact	JOEL KENT 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	12/22/1997
Decision Date	06/02/1998
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