TEMPALERT LIQUID CRYSTAL THERMOMETER
FDA 510(k) clearance K850797 · decided 1985-04-05
Clearance details
- K-number
- K850797
- Device name
- TEMPALERT LIQUID CRYSTAL THERMOMETER
- Applicant
- Medical Frontiers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-02-27
- Decision date
- 1985-04-05
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- KPD
- Device class
- 2
- Regulation number
- 880.2200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Centerville, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medical Frontiers
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| E-Z TEMP II (K934941) | Seven C'S, Inc. | 1994-07-27 |
| TEMP MARQ TEMPERATURE TREND INDICATOR (K903307) | Marquest Medical Products, Inc. | 1990-08-17 |
| FEVER LINE AND FEVER LINE PLUS (K893803) | Liquid Crystal Sciences, Inc. | 1989-08-21 |
| OMNI THERM TEMPERATURE MONITOR (K864853) | Omni Therm, Inc. | 1987-02-04 |
| TEMPTREND PEDS AXILLARY TEMP. INDICATOR (K841913) | Biosynergy, Inc. | 1984-11-02 |
| TEMPTREND II (K833904) | Biosynergy, Inc. | 1983-12-27 |
| ATI FOREHEAD THERMOMETER (K832651) | American Thermal Instruments, Inc. | 1983-10-04 |
| ACCA-TEMP SKIN TEMP. VINYL DISC (K823221) | T. G. & E. Medical | 1983-01-12 |
| TEMPTREND TEMPERATURE TREND INDICATOR (K821312) | Liquid Crystal Products, Inc. | 1982-05-28 |
| TEMPERATURE TREND INDICATOR (TTI) (K820426) | Mon-A-Therm, Inc. | 1982-03-08 |
| SKIN TEMPERATURE SENSING VINYL STRIP (K813199) | T. G. & E. Medical | 1982-03-05 |
| LIQUID CRYSTAL THERM. 8 EVENT MONITOR (K802778) | Djinnii Industires, Inc. | 1981-01-09 |
Recalls involving this device
No recalls on record reference this clearance.