Geratherm Mercuiry Free Clinical Thermometer

FDA 510(k) K960224 · Rg Ent., Inc.

Substantially Equivalent

510(k) numberK960224

Submission

Device name
Geratherm Mercuiry Free Clinical Thermometer
Applicant
Rg Ent., Inc.
Waterford, MI, US
Received
January 17, 1996
Decision date
March 25, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FLK – Thermometer, Clinical Mercury
Device class
Class II (moderate risk)
Regulation
21 CFR 880.2920
Specialty
General Hospital

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K953465KentempFLK · Traditional Kentron Health Care, Inc.12/15/1995SE
K942483Clinical Glass ThermometerFLK · Traditional Makol Medical Instruments Corp.03/28/1995SE
K941673Mediaid Universal ThermometerFLK · Traditional Polymedica Industries, Inc.08/25/1994SE
K940394Amg Med Brand Clinical Glass ThermometerFLK · Traditional Technolab Industries (Canada) , Ltd.05/04/1994SE
K940380Amg Med Brand Clinical Glass ThermometerFLK · Traditional Amg Medical, Inc.05/04/1994SE
K932991Guardian and Andino ModelsFLK · Traditional Coltemp, Inc.01/28/1994SE
K923225Lorrex Health Products - Clinical Mercury ThermomeFLK · Traditional Lorrex Health Products06/08/1993SE
K913793Simpex Inc. Oral and Rectal ThermometersFLK · Traditional Simpex, Inc.12/30/1991SE
K911269Mercury and Glass Fever ThermometerFLK · Traditional Steridyne Corp.05/15/1991SE

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Questions and answers

When was Geratherm Mercuiry Free Clinical Thermometer cleared by the FDA?

Geratherm Mercuiry Free Clinical Thermometer (K960224) received a 510(k) decision of Substantially Equivalent on March 25, 1996, 68 days after the submission was received.

What is the product code of K960224?

The FDA product code is FLK – Thermometer, Clinical Mercury, a Class II (moderate risk) device regulated under 21 CFR 880.2920.