K772138 is an FDA 510(k) clearance for the ENDOTRACHEAL TUBE. This device is classified as a Tube, Tracheostomy (w/wo Connector) (Class II - Special Controls, product code BTO).
Submitted by Medline Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 20, 1977, 36 days after receiving the submission on November 14, 1977.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K772138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 1977 |
| Decision Date | December 20, 1977 |
| Days to Decision | 36 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 |