K850797 is an FDA 510(k) clearance for the TEMPALERT LIQUID CRYSTAL THERMOMETER. This device is classified as a Strip, Temperature, Forehead, Liquid Crystal (Class II - Special Controls, product code KPD).
Submitted by Medical Frontiers, Inc. (Centerville, US). The FDA issued a Cleared decision on April 5, 1985, 37 days after receiving the submission on February 27, 1985.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2200.
| 510(k) Number | K850797 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 1985 |
| Decision Date | April 05, 1985 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KPD — Strip, Temperature, Forehead, Liquid Crystal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2200 |