Temptrend Temperature Trend Indicator

FDA 510(k) K821312 · Liquid Crystal Products, Inc.

Substantially Equivalent

510(k) numberK821312

Submission

Device name
Temptrend Temperature Trend Indicator
Applicant
Liquid Crystal Products, Inc.
Walker, MI, US
Received
May 4, 1982
Decision date
May 28, 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
K820426Temperature Trend Indicator (Tti)KPD · Traditional Mon-A-Therm, Inc.03/08/1982SE

More from Mon-A-Therm, Inc.

510(k)DeviceDecision
K800666Quik-TempKPP · Traditional 05/08/1980SE
K800667Monitemp Blood Pack Temp. MonitorKSE · Traditional 04/16/1980SE

Questions and answers

When was Temptrend Temperature Trend Indicator cleared by the FDA?

Temptrend Temperature Trend Indicator (K821312) received a 510(k) decision of Substantially Equivalent on May 28, 1982, 24 days after the submission was received.

What is the product code of K821312?

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