FDA 510(k) Application Details - K050175

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K050175
Device Name	Detector And Alarm, Arrhythmia
Applicant	SPACELABS MEDICAL, INC. 5150 220TH AVE SE P.O. BOX 7018 ISSAQUAH, WA 98027-7018 US Other 510(k) Applications for this Company
Contact	AL VAN HOUDT 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	01/26/2005
Decision Date	03/04/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review