FDA 510(k) Application Details - K963120

Device Classification Name	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)   More FDA Info for this Device
510(K) Number	K963120
Device Name	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Applicant	MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. MILWAUKEE, WI 53223 US Other 510(k) Applications for this Company
Contact	KRISTIN PABST 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	08/12/1996
Decision Date	02/28/1997
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