K841913 is an FDA 510(k) clearance for the TEMPTREND PEDS AXILLARY TEMP. INDICATOR. This device is classified as a Strip, Temperature, Forehead, Liquid Crystal (Class II - Special Controls, product code KPD).
Submitted by Biosynergy, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on November 2, 1984, 177 days after receiving the submission on May 9, 1984.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2200.
| 510(k) Number | K841913 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 1984 |
| Decision Date | November 02, 1984 |
| Days to Decision | 177 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 |