510(k) K163708

QiF Blood and Fluid Warmer by Quality IN Flow , Ltd. — Product Code LGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2017
Date Received
December 29, 2016
Clearance Type
Special
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