Cleared Traditional

MEDIAID UNIVERSAL THERMOMETER

K941673 · Polymedica Industries, Inc. · General Hospital
Aug 1994
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K941673 is an FDA 510(k) clearance for the MEDIAID UNIVERSAL THERMOMETER, a Thermometer, Clinical Mercury (Class II — Special Controls, product code FLK), submitted by Polymedica Industries, Inc. (Golden, US). The FDA issued a Cleared decision on August 25, 1994, 142 days after receiving the submission on April 5, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2920.

Submission Details

510(k) Number K941673 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 1994
Decision Date August 25, 1994
Days to Decision 142 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FLK — Thermometer, Clinical Mercury
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2920

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