Cleared Traditional

QiF Blood and Fluid Warmer

K171215 · Quality IN Flow , Ltd. · General Hospital
Sep 2017
Decision
155d
Days
Class 2
Risk

About This 510(k) Submission

K171215 is an FDA 510(k) clearance for the QiF Blood and Fluid Warmer, a Warmer, Thermal, Infusion Fluid (Class II — Special Controls, product code LGZ), submitted by Quality IN Flow , Ltd. (Kibutz Einat, IL). The FDA issued a Cleared decision on September 27, 2017, 155 days after receiving the submission on April 25, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K171215 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2017
Decision Date September 27, 2017
Days to Decision 155 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LGZ — Warmer, Thermal, Infusion Fluid
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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