FDA 510(k) Application Details - K964190

Device Classification Name	Pulse-Generator, Pacemaker, External   More FDA Info for this Device
510(K) Number	K964190
Device Name	Pulse-Generator, Pacemaker, External
Applicant	BIOTRONIK, INC. 6024 JEAN ROAD LAKE OSWEGO, OR 97035 US Other 510(k) Applications for this Company
Contact	Joseph J Schwoebel Other 510(k) Applications for this Contact
Regulation Number	870.3600   More FDA Info for this Regulation Number
Classification Product Code	DTE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/21/1996
Decision Date	07/10/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review