FDA 510(k) Application Details - K011328

Device Classification Name	System, Ecg Analysis   More FDA Info for this Device
510(K) Number	K011328
Device Name	System, Ecg Analysis
Applicant	BIONET COMPANY LTD 3F, DAEYANG BLDG., 999 DAECHI-DONG, KANGNAM-GU SEOUL KR Other 510(k) Applications for this Company
Contact	MIN SOO HAN 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	05/01/2001
Decision Date	11/21/2001
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