FDA 510(k) Application Details - K011339

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K011339
Device Name	Detector And Alarm, Arrhythmia
Applicant	SPACELABS BURDICK, INC. 20310 SW 48TH ST. FT. LAUDERDALE, FL 33332 US Other 510(k) Applications for this Company
Contact	JOHN E GREENBAUM 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	05/02/2001
Decision Date	08/20/2001
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