Disposable Temperature Probe
FDA 510(k) K770353 · Inhal-O-Tech Medical Plastic
510(k) numberK770353
Submission
- Device name
- Disposable Temperature Probe
- Applicant
- Inhal-O-Tech Medical Plastic
Blue Springs, MO, US - Received
- February 22, 1977
- Decision date
- March 16, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | Device | Applicant | Decision |
|---|---|---|---|
| K934941 | E-Z Temp IIKPD · Traditional | Seven C'S, Inc. | 07/27/1994SE |
| K903307 | Temp Marq Temperature Trend IndicatorKPD · Traditional | Marquest Medical Products, Inc. | 08/17/1990SE |
| K893803 | Fever Line and Fever Line PlusKPD · Traditional | Liquid Crystal Sciences, Inc. | 08/21/1989SE |
| K864853 | Omni Therm Temperature MonitorKPD · Traditional | Omni Therm, Inc. | 02/04/1987SE |
| K850797 | Tempalert Liquid Crystal ThermometerKPD · Traditional | Medical Frontiers, Inc. | 04/05/1985SE |
| K841913 | Temptrend Peds Axillary Temp. IndicatorKPD · Traditional | Biosynergy, Inc. | 11/02/1984SE |
| K833904 | Temptrend IIKPD · Traditional | Biosynergy, Inc. | 12/27/1983SE |
| K832651 | Ati Forehead ThermometerKPD · Traditional | American Thermal Instruments, Inc. | 10/04/1983SE |
| K823221 | Acca-Temp Skin Temp. Vinyl DiscKPD · Traditional | T. G. & E. Medical | 01/12/1983SE |
| K821312 | Temptrend Temperature Trend IndicatorKPD · Traditional | Liquid Crystal Products, Inc. | 05/28/1982SE |
More from Liquid Crystal Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K781741 | Mask, Bi Flo Nasal OxygenBYG · Traditional | 12/01/1978SE |
| K781394 | Disposable Incentive SpirometerCCQ · Traditional | 10/16/1978SE |
| K781395 | Disposable Aerosol T Briggs AdaptorBZA · Traditional | 08/31/1978SE |
| K770354 | Tubing, Aerosal, DisposableBZO · Traditional | 03/16/1977SE |
| K760329 | Mask, Disposable Oxygen TherapyBYG · Traditional | 09/30/1976SE |
| K760330 | Cannula, Disposable Oxygen TtherapyCAT · Traditional | 08/04/1976SE |
Questions and answers
When was Disposable Temperature Probe cleared by the FDA?
Disposable Temperature Probe (K770353) received a 510(k) decision of Substantially Equivalent on March 16, 1977, 22 days after the submission was received.
What is the product code of K770353?
The FDA product code is KPD – Strip, Temperature, Forehead, Liquid Crystal, a Class II (moderate risk) device regulated under 21 CFR 880.2200.