FDA 510(k) Application Details - K081444

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K081444
Device Name	Detector And Alarm, Arrhythmia
Applicant	BRAEMAR, INC. 1285 CORPORATE CENTER DR. SUITE 150 EAGAN, MN 55121 US Other 510(k) Applications for this Company
Contact	DARREN DERSHEM 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	05/22/2008
Decision Date	07/31/2008
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