FDA 510(k) Application Details - K121158

Device Classification Name	Catheter, Recording, Electrode, Reprocessed   More FDA Info for this Device
510(K) Number	K121158
Device Name	Catheter, Recording, Electrode, Reprocessed
Applicant	STERILMED, INC. 11400 73RD AVE. NORTH MAPLE GROVE, MN 55369 US Other 510(k) Applications for this Company
Contact	JASON SKRAMSTED 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	04/16/2012
Decision Date	08/06/2012
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