Temp Marq Temperature Trend Indicator
FDA 510(k) K903307 · Marquest Medical Products, Inc.
510(k) numberK903307
Submission
- Device name
- Temp Marq Temperature Trend Indicator
- Applicant
- Marquest Medical Products, Inc.
Englewood, CO, US - Received
- July 24, 1990
- Decision date
- August 17, 1990
- 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 |
| 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 |
| K820426 | Temperature Trend Indicator (Tti)KPD · Traditional | Mon-A-Therm, Inc. | 03/08/1982SE |
More from Mon-A-Therm, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K050066 | C-CO2 Colorimetric CO2 IndicatorCCK · Traditional | 03/01/2005SE |
| K970478 | SCT 3000 Heated HumidifierBTT · Traditional | 07/16/1997SE |
| K962223 | Water Chambers for ST 3000 Heated HumidifierBTT · Traditional | 01/14/1997SE |
| K962220 | Heated Wire Circuits for SCT 3000 Heated HumidifierBZE · Traditional | 01/14/1997SE |
| K961838 | Respirgard II, SpirogardCAH · Traditional | 10/18/1996SE |
| K960972 | Disposable Gas Sampling Interface KitsCCK · Traditional | 10/18/1996SE |
| K904690 | Temp Marq(Tm) Convective Warming SystemDWJ · Traditional | 02/01/1991SE |
| K903138 | Marquest SCT 3000, Heated Humidification SystemBTT · Traditional | 10/11/1990SE |
| K902632 | Gas-Lyte 1CC and 3CC Arterial Blood SamplersCBT · Traditional | 09/04/1990SE |
| K880979 | Marquest SCT 2000, Heated Humidification SystemBTT · Traditional | 07/15/1988SE |
Questions and answers
When was Temp Marq Temperature Trend Indicator cleared by the FDA?
Temp Marq Temperature Trend Indicator (K903307) received a 510(k) decision of Substantially Equivalent on August 17, 1990, 24 days after the submission was received.
What is the product code of K903307?
The FDA product code is KPD – Strip, Temperature, Forehead, Liquid Crystal, a Class II (moderate risk) device regulated under 21 CFR 880.2200.