Cleared Traditional

8NONE

K041839 · Medical Solutions, Inc. · General Hospital
Feb 2005
Decision
222d
Days
Class 2
Risk

About This 510(k) Submission

K041839 is an FDA 510(k) clearance for the 8NONE, a Warmer, Thermal, Infusion Fluid (Class II — Special Controls, product code LGZ), submitted by Medical Solutions, Inc. (Crofton, US). The FDA issued a Cleared decision on February 15, 2005, 222 days after receiving the submission on July 8, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K041839 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2004
Decision Date February 15, 2005
Days to Decision 222 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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