Amg Med Brand Clinical Glass Thermometer

FDA 510(k) K940394 · Technolab Industries (Canada) , Ltd.

Substantially Equivalent

510(k) numberK940394

Submission

Device name
Amg Med Brand Clinical Glass Thermometer
Applicant
Technolab Industries (Canada) , Ltd.
Montreal, Quebec, CA
Received
January 26, 1994
Decision date
May 4, 1994
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

Other 510(k)s with product code FLK

510(k)DeviceApplicantDecision
K960185Amsino Clinical ThermometerFLK · Traditional Amsia Intl., Inc.03/28/1996SE
K960224Geratherm Mercuiry Free Clinical ThermometerFLK · Traditional Rg Ent., Inc.03/25/1996SE
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
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

Questions and answers

When was Amg Med Brand Clinical Glass Thermometer cleared by the FDA?

Amg Med Brand Clinical Glass Thermometer (K940394) received a 510(k) decision of Substantially Equivalent on May 4, 1994, 98 days after the submission was received.

What is the product code of K940394?

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