FDA 510(k) Application Details - K011734

Device Classification Name	Catheter, Electrode Recording, Or Probe, Electrode Recording   More FDA Info for this Device
510(K) Number	K011734
Device Name	Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant	MOGUL ENTERPRISES 6387 SAN IGNACIO AVE. SAN JOSE, CA 95119 US Other 510(k) Applications for this Company
Contact	JAMIL MOGUL 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	06/05/2001
Decision Date	07/03/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review