K771385 is an FDA 510(k) clearance for the 2 JET SET. This device is classified as a Mask, Oxygen, Low Concentration, Venturi (Class I - General Controls, product code BYF).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on August 4, 1977, 8 days after receiving the submission on July 27, 1977.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5600.
| 510(k) Number | K771385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 1977 |
| Decision Date | August 04, 1977 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BYF — Mask, Oxygen, Low Concentration, Venturi |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5600 |