FDA 510(k) Application Details - K090895

Device Classification Name	System, Ecg Analysis   More FDA Info for this Device
510(K) Number	K090895
Device Name	System, Ecg Analysis
Applicant	BIONET CO., LTD. ROOM 431, LIFEOFFICETEL 61-3, YOIDO-DONG, YOUNGDEUNGPO -GU, SEOUL 150-731 KR Other 510(k) Applications for this Company
Contact	HL JUNG Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LOS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/2009
Decision Date	08/26/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review