FDA 510(k) Application Details - K082023

Device Classification Name	Catheter, Recording, Electrode, Reprocessed   More FDA Info for this Device
510(K) Number	K082023
Device Name	Catheter, Recording, Electrode, Reprocessed
Applicant	ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. PHOENIX, AZ 85044 US Other 510(k) Applications for this Company
Contact	AMANDA BABCOCK Other 510(k) Applications for this Contact
Regulation Number	870.1220   More FDA Info for this Regulation Number
Classification Product Code	NLH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/16/2008
Decision Date	09/16/2008
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