FDA 510(k) Application Details - K974034

Device Classification Name	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)   More FDA Info for this Device
510(K) Number	K974034
Device Name	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Applicant	MEDICAL RESEARCH LABORATORIES, INC. 1000 ASBURY DR. NO.17 BUFFALO GROVE, IL 60089 US Other 510(k) Applications for this Company
Contact	JOEL ORLINSKY Other 510(k) Applications for this Contact
Regulation Number	870.5550   More FDA Info for this Regulation Number
Classification Product Code	DRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/1997
Decision Date	03/02/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review