Cleared Traditional

TEMP 3

K012276 · Medical Solutions, Inc. · General Hospital
Aug 2001
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K012276 is an FDA 510(k) clearance for the TEMP 3, a Warmer, Thermal, Infusion Fluid (Class II — Special Controls, product code LGZ), submitted by Medical Solutions, Inc. (Chantilly, US). The FDA issued a Cleared decision on August 20, 2001, 32 days after receiving the submission on July 19, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K012276 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2001
Decision Date August 20, 2001
Days to Decision 32 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

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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