Temptrend II

FDA 510(k) K833904 · Biosynergy, Inc.

Substantially Equivalent

510(k) numberK833904

Submission

Device name
Temptrend II
Applicant
Biosynergy, Inc.
Mchenry, IL, US
Received
November 14, 1983
Decision date
December 27, 1983
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
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
K820426Temperature Trend Indicator (Tti)KPD · Traditional Mon-A-Therm, Inc.03/08/1982SE

More from Mon-A-Therm, Inc.

510(k)DeviceDecision
K841913Temptrend Peds Axillary Temp. IndicatorKPD · Traditional 11/02/1984SE

Questions and answers

When was Temptrend II cleared by the FDA?

Temptrend II (K833904) received a 510(k) decision of Substantially Equivalent on December 27, 1983, 43 days after the submission was received.

What is the product code of K833904?

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