K760039 is an FDA 510(k) clearance for the VALVE, I.M.V. (U-MID ONE WAY). This device is classified as a Attachment, Intermittent Mandatory Ventilation (imv) (Class II - Special Controls, product code CBO).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on July 16, 1976, 31 days after receiving the submission on June 15, 1976.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5955.
| 510(k) Number | K760039 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1976 |
| Decision Date | July 16, 1976 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CBO — Attachment, Intermittent Mandatory Ventilation (imv) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5955 |