FDA 510(k) Application Details - K963190

Device Classification Name	Tester, Defibrillator   More FDA Info for this Device
510(K) Number	K963190
Device Name	Tester, Defibrillator
Applicant	METRON U.S., INC. 1345 MONROE, N.W., #255A GRAND RAPIDS, MI 49505 US Other 510(k) Applications for this Company
Contact	JIM QUINN Other 510(k) Applications for this Contact
Regulation Number	870.5325   More FDA Info for this Regulation Number
Classification Product Code	DRL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/1996
Decision Date	07/01/1997
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