Skin Temperature Sensing Vinyl Strip

FDA 510(k) K813199 · T. G. & E. Medical

Substantially Equivalent

510(k) numberK813199

Submission

Device name
Skin Temperature Sensing Vinyl Strip
Applicant
T. G. & E. Medical
Mchenry, IL, US
Received
November 13, 1981
Decision date
March 5, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KPD – Strip, Temperature, Forehead, Liquid Crystal
Device class
Class II (moderate risk)
Regulation
21 CFR 880.2200
Specialty
General Hospital

Other 510(k)s with product code KPD

510(k)DeviceApplicantDecision
K934941E-Z Temp IIKPD · Traditional Seven C'S, Inc.07/27/1994SE
K903307Temp Marq Temperature Trend IndicatorKPD · Traditional Marquest Medical Products, Inc.08/17/1990SE
K893803Fever Line and Fever Line PlusKPD · Traditional Liquid Crystal Sciences, Inc.08/21/1989SE
K864853Omni Therm Temperature MonitorKPD · Traditional Omni Therm, Inc.02/04/1987SE
K850797Tempalert Liquid Crystal ThermometerKPD · Traditional Medical Frontiers, Inc.04/05/1985SE
K841913Temptrend Peds Axillary Temp. IndicatorKPD · Traditional Biosynergy, Inc.11/02/1984SE
K833904Temptrend IIKPD · Traditional Biosynergy, Inc.12/27/1983SE
K832651Ati Forehead ThermometerKPD · Traditional American Thermal Instruments, Inc.10/04/1983SE
K823221Acca-Temp Skin Temp. Vinyl DiscKPD · Traditional T. G. & E. Medical01/12/1983SE
K821312Temptrend Temperature Trend IndicatorKPD · Traditional Liquid Crystal Products, Inc.05/28/1982SE

More from Liquid Crystal Products, Inc.

510(k)DeviceDecision
K860706IV Band (Intravenous Catheter Assesory)KMK · Traditional 03/21/1986SE
K860261Cannula BandCAT · Traditional 02/18/1986SE
K823221Acca-Temp Skin Temp. Vinyl DiscKPD · Traditional 01/12/1983SE
K820941Therma-Scan · Traditional 06/16/1982SE

Questions and answers

When was Skin Temperature Sensing Vinyl Strip cleared by the FDA?

Skin Temperature Sensing Vinyl Strip (K813199) received a 510(k) decision of Substantially Equivalent on March 5, 1982, 112 days after the submission was received.

What is the product code of K813199?

The FDA product code is KPD – Strip, Temperature, Forehead, Liquid Crystal, a Class II (moderate risk) device regulated under 21 CFR 880.2200.