K780260 is an FDA 510(k) clearance for the TEMP. SENSOR W/22MM FITTINGS. This device is classified as a Strip, Temperature, Forehead, Liquid Crystal (Class II - Special Controls, product code KPD).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on March 14, 1978, 27 days after receiving the submission on February 15, 1978.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2200.
| 510(k) Number | K780260 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 1978 |
| Decision Date | March 14, 1978 |
| Days to Decision | 27 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 |