FDA 510(k) Application Details - K023034

Device Classification Name	System, Ecg Analysis   More FDA Info for this Device
510(K) Number	K023034
Device Name	System, Ecg Analysis
Applicant	BIONET COMPANY LTD 1308 MORNINGSIDE PARK DR. ALPHARETTA, GA 30022 US Other 510(k) Applications for this Company
Contact	JAY MANSOUR 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	09/12/2002
Decision Date	11/14/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review