510(k) K132110

NATUS WARMETTE BLANKET AND DUAL CABINETS by Natus Nicolet Ireland, Ltd. — Product Code LGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2013
Date Received
July 9, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Thermal, Infusion Fluid
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type