Liquid Crystal Therm. 8 Event Monitor
FDA 510(k) K802778 · Djinnii Industires, Inc.
510(k) numberK802778
Submission
- Device name
- Liquid Crystal Therm. 8 Event Monitor
- Applicant
- Djinnii Industires, Inc.
Mchenry, IL, US - Received
- November 5, 1980
- Decision date
- January 9, 1981
- 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 |
Questions and answers
When was Liquid Crystal Therm. 8 Event Monitor cleared by the FDA?
Liquid Crystal Therm. 8 Event Monitor (K802778) received a 510(k) decision of Substantially Equivalent on January 9, 1981, 65 days after the submission was received.
What is the product code of K802778?
The FDA product code is KPD – Strip, Temperature, Forehead, Liquid Crystal, a Class II (moderate risk) device regulated under 21 CFR 880.2200.