K062104 is an FDA 510(k) clearance for the TALKING TRACH. This device is classified as a Tube, Tracheostomy (w/wo Connector) (Class II - Special Controls, product code BTO).
Submitted by Engineered Medical Systems, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on April 20, 2007, 270 days after receiving the submission on July 24, 2006.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K062104 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2006 |
| Decision Date | April 20, 2007 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTO - Tube, Tracheostomy (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5800 |