K841546 is an FDA 510(k) clearance for the COMMUNI-TRACH TUBE. This device is classified as a Tube, Tracheostomy (w/wo Connector) (Class II - Special Controls, product code BTO).
Submitted by Implant Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 30, 1984, 14 days after receiving the submission on April 16, 1984.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K841546 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 1984 |
| Decision Date | April 30, 1984 |
| Days to Decision | 14 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 |