K832466 is an FDA 510(k) clearance for the TRACHEAL TUBE 16 GAUGE-1.65MM-. This device is classified as a Tube, Tracheostomy (w/wo Connector) (Class II - Special Controls, product code BTO).
Submitted by Erie Medical (Walker, US). The FDA issued a Cleared decision on September 19, 1984, 421 days after receiving the submission on July 26, 1983.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K832466 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 1983 |
| Decision Date | September 19, 1984 |
| Days to Decision | 421 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BTO — Tube, Tracheostomy (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5800 |