K100480 is an FDA 510(k) clearance for the ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH. This device is classified as a Tube, Tracheostomy (w/wo Connector) (Class II - Special Controls, product code BTO).
Submitted by Vitaltec Corporation (Hsin Chu City, TW). The FDA issued a Cleared decision on June 11, 2010, 113 days after receiving the submission on February 18, 2010.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K100480 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2010 |
| Decision Date | June 11, 2010 |
| Days to Decision | 113 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 |