FDA 510(k) Application Details - K090249

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K090249
Device Name	Electrocardiograph
Applicant	HARBINGER MEDICAL, INC. 10125 CROSSTOWN CIRCLE SUITE 105 EDEN PRAIRIE, MN 55344-3316 US Other 510(k) Applications for this Company
Contact	HAROLD HOIUM Other 510(k) Applications for this Contact
Regulation Number	870.2340   More FDA Info for this Regulation Number
Classification Product Code	DPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/2009
Decision Date	04/03/2009
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