FDA 510(k) Application Details - K952790

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K952790
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant	NIAN-CRAE, INC. 13 CORTLAND DR. SOMERSET, NJ 08873 US Other 510(k) Applications for this Company
Contact	NICKI ANN NEWBY 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	06/19/1995
Decision Date	10/17/1996
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