510(k) K180154

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2018
Date Received
January 19, 2018
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