K811631 is an FDA 510(k) clearance for the THERMOMETER (MADE IN CHINA). This device is classified as a Thermometer, Clinical Mercury (Class II - Special Controls, product code FLK).
Submitted by Robert I. Chien & Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1981, 41 days after receiving the submission on June 9, 1981.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2920.
| 510(k) Number | K811631 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 1981 |
| Decision Date | July 20, 1981 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FLK — Thermometer, Clinical Mercury |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2920 |