KPD · Strip, Temperature, Forehead, Liquid Crystal
General Hospital · 21 CFR 880.2200 · Class 2
Overview
| Product Code | KPD |
|---|---|
| Device Name | Strip, Temperature, Forehead, Liquid Crystal |
| Regulation | 21 CFR 880.2200 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A liquid crystal forehead temperature strip is a device applied to the forehead that is used to indicate the presence or absence of fever, or to monitor body temperature changes. The device displays the color changes of heat sensitive liquid crystals corresponding to the variation in the surface temperature of the skin. The liquid crystals, which are cholesteric esters, are sealed in plastic.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Recent Cleared Devices (20 of 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K934941 | E-Z TEMP II | Seven C'S, Inc. | Jul 27, 1994 | SESE |
| K903307 | TEMP MARQ TEMPERATURE TREND INDICATOR | Marquest Medical Products, Inc. | Aug 17, 1990 | SESE |
| K893803 | FEVER LINE AND FEVER LINE PLUS | Liquid Crystal Sciences, Inc. | Aug 21, 1989 | SESE |
| K864853 | OMNI THERM TEMPERATURE MONITOR | Omni Therm, Inc. | Feb 4, 1987 | SESE |
| K850797 | TEMPALERT LIQUID CRYSTAL THERMOMETER | Medical Frontiers, Inc. | Apr 5, 1985 | SESE |
| K841913 | TEMPTREND PEDS AXILLARY TEMP. INDICATOR | Biosynergy, Inc. | Nov 2, 1984 | SESE |
| K833904 | TEMPTREND II | Biosynergy, Inc. | Dec 27, 1983 | SESE |
| K832651 | ATI FOREHEAD THERMOMETER | American Thermal Instruments, Inc. | Oct 4, 1983 | SESE |
| K823221 | ACCA-TEMP SKIN TEMP. VINYL DISC | T. G. & E. Medical | Jan 12, 1983 | SESE |
| K821312 | TEMPTREND TEMPERATURE TREND INDICATOR | Liquid Crystal Products, Inc. | May 28, 1982 | SESE |
| K820426 | TEMPERATURE TREND INDICATOR (TTI) | Mon-A-Therm, Inc. | Mar 8, 1982 | SESE |
| K813199 | SKIN TEMPERATURE SENSING VINYL STRIP | T. G. & E. Medical | Mar 5, 1982 | SESE |
| K802778 | LIQUID CRYSTAL THERM. 8 EVENT MONITOR | Djinnii Industires, Inc. | Jan 9, 1981 | SESE |
| K802897 | ELECTRONIC DIGITAL THERMOMETER | Philip J. Teders | Dec 16, 1980 | SESE |
| K790532 | FEVER TESTER | Maddak, Inc. | May 29, 1979 | SESE |
| K780580 | TEMPERATURE INDICATOR | Respiratory Care, Inc. | Apr 27, 1978 | SESE |
| K780260 | TEMP. SENSOR W/22MM FITTINGS | Bd Becton Dickinson Vacutainer Systems Preanalytic | Mar 14, 1978 | SESE |
| K771980 | FEVER TESTER | American Thermometer Company, Inc. | Nov 2, 1977 | SESE |
| K770517 | NF DEVICE | Rpr, Inc. | Jul 15, 1977 | SESE |
| K770353 | DISPOSABLE TEMPERATURE PROBE | Inhal-O-Tech Medical Plastic | Mar 16, 1977 | SESE |
Top Applicants
- Biosynergy, Inc. — 2 clearances
- Respiratory Care, Inc. — 2 clearances
- T. G. & E. Medical — 2 clearances
- American Thermal Instruments, Inc. — 1 clearance
- American Thermometer Company, Inc. — 1 clearance
