FDA 510(k) Application Details - K974352

Device Classification Name	System, Ecg Analysis   More FDA Info for this Device
510(K) Number	K974352
Device Name	System, Ecg Analysis
Applicant	MICROMEDICAL, INC. 255 REVERE DR., SUITE 111 NORTHBROOK, IL 60062 US Other 510(k) Applications for this Company
Contact	MALCOM CASTLE 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	11/19/1997
Decision Date	09/08/1998
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