Cleared Traditional

GERATHERM MERCUIRY FREE CLINICAL THERMOMETER

K960224 · Rg Ent., Inc. · General Hospital

Mar 1996

Decision

68d

Days

Class 2

Risk

About This 510(k) Submission

K960224 is an FDA 510(k) clearance for the GERATHERM MERCUIRY FREE CLINICAL THERMOMETER, a Thermometer, Clinical Mercury (Class II — Special Controls, product code FLK), submitted by Rg Ent., Inc. (Waterford, US). The FDA issued a Cleared decision on March 25, 1996, 68 days after receiving the submission on January 17, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2920.

Submission Details

510(k) Number	K960224 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 1996
Decision Date	March 25, 1996
Days to Decision	68 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement