FDA 510(k) Application Details - K984089

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K984089
Device Name	Detector And Alarm, Arrhythmia
Applicant	ZYMED MEDICAL INSTRUMENTATION 20 NORTH AVIADOR ST. CAMARILLO, CA 93010 US Other 510(k) Applications for this Company
Contact	DUDLEY HARRIS 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	11/16/1998
Decision Date	02/16/1999
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