Simpex Inc. Oral and Rectal Thermometers

FDA 510(k) K913793 · Simpex, Inc.

Substantially Equivalent

510(k) numberK913793

Submission

Device name
Simpex Inc. Oral and Rectal Thermometers
Applicant
Simpex, Inc.
Jenkintown, PA, US
Received
August 23, 1991
Decision date
December 30, 1991
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
K911269Mercury and Glass Fever ThermometerFLK · Traditional Steridyne Corp.05/15/1991SE

More from Steridyne Corp.

510(k)DeviceDecision
K920174Easy Touch Latex Eam GlovesLYY · Traditional 04/22/1992SE
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K911505Fixation WireHTY · Traditional 04/12/1991SE
K911452Fixation PinHTY · Traditional 04/12/1991SE

Questions and answers

When was Simpex Inc. Oral and Rectal Thermometers cleared by the FDA?

Simpex Inc. Oral and Rectal Thermometers (K913793) received a 510(k) decision of Substantially Equivalent on December 30, 1991, 129 days after the submission was received.

What is the product code of K913793?

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