FDA 510(k) Application Details - K960542

Device Classification Name	Catheter, Electrode Recording, Or Probe, Electrode Recording   More FDA Info for this Device
510(K) Number	K960542
Device Name	Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant	BIOSENSE, LTD. EINSTEIN BUILDING, ETGAR ST. NEW INDUSTRIAL AREA, POB 297 TIRAT HACARMEL, HAIFA 39101 IL Other 510(k) Applications for this Company
Contact	SUSAN J ZACHMAN Other 510(k) Applications for this Contact
Regulation Number	870.1220   More FDA Info for this Regulation Number
Classification Product Code	DRF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/07/1996
Decision Date	04/15/1996
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