FDA 510(k) Application Details - K122012

Device Classification Name	More FDA Info for this Device
510(K) Number	K122012
Device Name	Z-MED Z-MED II
Applicant	NUMED, INC. 2880 MAIN ST. HOPKINTON, NY 12965 US Other 510(k) Applications for this Company
Contact	NICHELLE LAFLESH Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/10/2012
Decision Date	10/04/2012
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