FDA 510(k) Application Details - K965158

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K965158
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant	N.P.N.T., INC. 111 MARTIN ROSS AVENUE, UNIT #4 DOWNSVIEW, ONTARIO M3J-2M7 CA Other 510(k) Applications for this Company
Contact	KEN NUSBAUM 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	12/23/1996
Decision Date	12/09/1997
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