K833904 is an FDA 510(k) clearance for the TEMPTREND II. This device is classified as a Strip, Temperature, Forehead, Liquid Crystal (Class II - Special Controls, product code KPD).
Submitted by Biosynergy, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1983, 43 days after receiving the submission on November 14, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2200.
| 510(k) Number | K833904 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 1983 |
| Decision Date | December 27, 1983 |
| Days to Decision | 43 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 |