FDA 510(k) Application Details - K973918

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K973918
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant	NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. IRVINE, CA 92612-1601 US Other 510(k) Applications for this Company
Contact	GARY REASONER Other 510(k) Applications for this Contact
Regulation Number	870.2300   More FDA Info for this Regulation Number
Classification Product Code	DRT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/1997
Decision Date	01/13/1998
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