Omni Therm Temperature Monitor

FDA 510(k) K864853 · Omni Therm, Inc.

Substantially Equivalent

510(k) numberK864853

Submission

Device name
Omni Therm Temperature Monitor
Applicant
Omni Therm, Inc.
St. Louis, MO, US
Received
December 11, 1986
Decision date
February 4, 1987
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
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
K820426Temperature Trend Indicator (Tti)KPD · Traditional Mon-A-Therm, Inc.03/08/1982SE

More from Mon-A-Therm, Inc.

510(k)DeviceDecision
K961176Omni Cold Gel PacksIMD · Traditional 09/04/1996SE
K955788Imni Hot PacksIMD · Traditional 09/04/1996SE
K954877Omni Cold Gel PacksIMD · Traditional 02/13/1996SN
K936084Omni Warm Gel PacksIMD · Traditional 03/31/1994SE

Questions and answers

When was Omni Therm Temperature Monitor cleared by the FDA?

Omni Therm Temperature Monitor (K864853) received a 510(k) decision of Substantially Equivalent on February 4, 1987, 55 days after the submission was received.

What is the product code of K864853?

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