FDA 510(k) Application Details - K042469

Device Classification Name	Electrocardiograph,Ambulatory(Without Analysis)   More FDA Info for this Device
510(K) Number	K042469
Device Name	Electrocardiograph,Ambulatory(Without Analysis)
Applicant	BRAEMAR, INC. 11481 RUPP DR. BURNSVILLE, MN 55337 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	09/13/2004
Decision Date	10/06/2004
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