FDA 510(k) Application Details - K042998

Device Classification Name	Catheter, Electrode Recording, Or Probe, Electrode Recording   More FDA Info for this Device
510(K) Number	K042998
Device Name	Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant	BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. DIAMOND BAR, CA 91765 US Other 510(k) Applications for this Company
Contact	MARK O'DONNELL 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	11/01/2004
Decision Date	09/29/2005
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