Temperature Indicator
FDA 510(k) K780580 · Respiratory Care, Inc.
510(k) numberK780580
Submission
- Device name
- Temperature Indicator
- Applicant
- Respiratory Care, Inc.
Mchenry, IL, US - Received
- April 10, 1978
- Decision date
- April 27, 1978
- 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 |
|---|---|---|
| K892230 | Rci Viral/Bacterial FilterCAH · Traditional | 08/28/1989SE |
| K884150 | Modified Conchatherm III Controlled HeaterBTT · Traditional | 11/21/1988SE |
| K881625 | Conchatherm III Plus Dual Heat Wire Servo ControllBZE · Traditional | 06/21/1988SE |
| K864147 | AquavalveBYH · Traditional | 12/05/1986SE |
| K863955 | Colby Level AlarmBTT · Traditional | 11/07/1986SE |
| K861555 | Circapak Universal Volume Ventilator CircuitBZD · Traditional | 06/05/1986SE |
| K834151 | Conchatherm LHF Humidifier HeaterBTT · Traditional | 01/13/1984SE |
| K833974 | Aquapak 020 Humidifier AdapterBTT · Traditional | 12/16/1983SE |
| K832453 | Slimb Single Limb Breathing CircuitCAI · Traditional | 10/27/1983SE |
| K811524 | AquacadeLHC · Traditional | 07/01/1981SE |
Questions and answers
When was Temperature Indicator cleared by the FDA?
Temperature Indicator (K780580) received a 510(k) decision of Substantially Equivalent on April 27, 1978, 17 days after the submission was received.
What is the product code of K780580?
The FDA product code is KPD – Strip, Temperature, Forehead, Liquid Crystal, a Class II (moderate risk) device regulated under 21 CFR 880.2200.