Cleared Traditional

CLINICAL GLASS THERMOMETER

K942483 · Makol Medical Instruments Corp. · General Hospital

Mar 1995

Decision

307d

Days

Class 2

Risk

About This 510(k) Submission

K942483 is an FDA 510(k) clearance for the CLINICAL GLASS THERMOMETER, a Thermometer, Clinical Mercury (Class II — Special Controls, product code FLK), submitted by Makol Medical Instruments Corp. (Miami, US). The FDA issued a Cleared decision on March 28, 1995, 307 days after receiving the submission on May 25, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2920.

Submission Details

510(k) Number	K942483 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 25, 1994
Decision Date	March 28, 1995
Days to Decision	307 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement