K821314 is an FDA 510(k) clearance for the FEVER METER. This device is classified as a Regulator, Vacuum (Class II - Special Controls, product code KDP).
Submitted by Steridyne Corp. (Walker, US). The FDA issued a Cleared decision on May 28, 1982, 24 days after receiving the submission on May 4, 1982.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K821314 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1982 |
| Decision Date | May 28, 1982 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KDP — Regulator, Vacuum |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |