FDA 510(k) Application Details - K972587

Device Classification Name	System, Ecg Analysis   More FDA Info for this Device
510(K) Number	K972587
Device Name	System, Ecg Analysis
Applicant	DR. LEE CO., LTD. 3722 AVE. SAUSALITO IRVINE, CA 92606 US Other 510(k) Applications for this Company
Contact	GREG HOLLAND 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	07/11/1997
Decision Date	08/21/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review