FDA 510(k) Application Details - K033613

Device Classification Name	Tester, Pacemaker Electrode Function   More FDA Info for this Device
510(K) Number	K033613
Device Name	Tester, Pacemaker Electrode Function
Applicant	BIOTRONIK, INC. 6024 JEAN ROAD LAKE OSWEGO, OR 97035 US Other 510(k) Applications for this Company
Contact	Jon Brumbaugh Other 510(k) Applications for this Contact
Regulation Number	870.3720   More FDA Info for this Regulation Number
Classification Product Code	DTA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/17/2003
Decision Date	12/08/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review