FDA 510(k) Application Details - K002061

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K002061
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant	A & D ENGINEERING, INC. 1555 MC CANDLESS DR. MILPITAS, CA 95035 US Other 510(k) Applications for this Company
Contact	JERRY WANG 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	07/06/2000
Decision Date	01/19/2001
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