FDA 510(k) Application Details - K961582

Device Classification Name	Analyzer, Pacemaker Generator Function   More FDA Info for this Device
510(K) Number	K961582
Device Name	Analyzer, Pacemaker Generator Function
Applicant	NORTH AMERICAN TECHNICAL SERVICES CORP. 30 NORTHPORT RD. SOUND BEACH, NY 11789-1734 US Other 510(k) Applications for this Company
Contact	RICHARD C LANZILLOTTO Other 510(k) Applications for this Contact
Regulation Number	870.3630   More FDA Info for this Regulation Number
Classification Product Code	DTC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/1996
Decision Date	11/08/1996
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