FDA 510(k) Application Details - K974581

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K974581
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant	INVIVO RESEARCH, INC. 12601 RESEARCH PKWY. ORLANDO, FL 32826 US Other 510(k) Applications for this Company
Contact	FRANCIS CASEY 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	12/08/1997
Decision Date	10/28/1998
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