FDA 510(k) Application Details - K071733

Device Classification Name	Electrocardiograph,Ambulatory(Without Analysis)   More FDA Info for this Device
510(K) Number	K071733
Device Name	Electrocardiograph,Ambulatory(Without Analysis)
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	870.2800   More FDA Info for this Regulation Number
Classification Product Code	MWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/26/2007
Decision Date	07/24/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review