FDA 510(k) Application Details - K013615

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K013615
Device Name	Electrocardiograph
Applicant	HARBINGER MEDICAL, INC. 12086 OXBOW DR. EDEN PRAIRE, MN 55347 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	11/05/2001
Decision Date	05/29/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review