Cleared Traditional

HEAT STACK

K980086 · Medical Solutions, Inc. · General Hospital
Mar 1998
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K980086 is an FDA 510(k) clearance for the HEAT STACK, 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 March 10, 1998, 60 days after receiving the submission on January 9, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K980086 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 1998
Decision Date March 10, 1998
Days to Decision 60 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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