FDA 510(k) Application Details - K023616

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K023616
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant	IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. BRANFORD, CT 06405 US Other 510(k) Applications for this Company
Contact	DICK LISTRO 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	10/29/2002
Decision Date	11/04/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review