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510(k) K171215

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2017
Date Received
April 25, 2017
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

Other clearances by Quality IN Flow , Ltd.

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  • K163708 — QiF Blood and Fluid Warmer (April 20, 2017)
  • K150404 — QiF Blood and Fluid Warmer (June 23, 2016)

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