FDA 510(k) Application Details - K011361

Device Classification Name	Catheter, Electrode Recording, Or Probe, Electrode Recording   More FDA Info for this Device
510(K) Number	K011361
Device Name	Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant	CATHEFFECTS, LLC. 1100 MELODY LANE; SUITE 108 ROSEVILLE, CA 95678 US Other 510(k) Applications for this Company
Contact	SHAWN FOJTIK 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	05/03/2001
Decision Date	09/06/2001
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