K810314 is an FDA 510(k) clearance for the WILLIAM HARVEY FLOWMETER SYSTEM. This device is classified as a Tube, Thorpe, Uncompensated (Class I - General Controls, product code BYM).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 19, 1981, 14 days after receiving the submission on February 5, 1981.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2320.
| 510(k) Number | K810314 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 1981 |
| Decision Date | February 19, 1981 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BYM — Tube, Thorpe, Uncompensated |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.2320 |