Cleared Traditional

HOTLINE FLUID WARMER

K911383 · Level 1 Technologies, Inc. · General Hospital
Oct 1991
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K911383 is an FDA 510(k) clearance for the HOTLINE FLUID WARMER, a Warmer, Thermal, Infusion Fluid (Class II — Special Controls, product code LGZ), submitted by Level 1 Technologies, Inc. (Potomac, US). The FDA issued a Cleared decision on October 17, 1991, 203 days after receiving the submission on March 28, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K911383 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 1991
Decision Date October 17, 1991
Days to Decision 203 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

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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