FDA 510(k) Application Details - K003576

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K003576
Device Name	Detector And Alarm, Arrhythmia
Applicant	QUINTON, INC. 3303 MONTE VILLA PKWY. BOTHELL, WA 98021-8906 US Other 510(k) Applications for this Company
Contact	DAVID HIMES Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	DSI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2000
Decision Date	01/25/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review