Cleared Traditional

DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET

K132202 · Enthermics Medical Systems, Inc. · General Hospital
Dec 2013
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K132202 is an FDA 510(k) clearance for the DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET, a Warmer, Thermal, Infusion Fluid (Class II — Special Controls, product code LGZ), submitted by Enthermics Medical Systems, Inc. (Menomonee Falls, US). The FDA issued a Cleared decision on December 6, 2013, 143 days after receiving the submission on July 16, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K132202 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2013
Decision Date December 06, 2013
Days to Decision 143 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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