K100950 is an FDA 510(k) clearance for the VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE. This device is classified as a Tube, Tracheostomy (w/wo Connector) (Class II - Special Controls, product code BTO).
Submitted by Venner Medical (Singapore) Pte, Ltd. (Dallas, US). The FDA issued a Cleared decision on July 13, 2010, 98 days after receiving the submission on April 6, 2010.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K100950 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2010 |
| Decision Date | July 13, 2010 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BTO - Tube, Tracheostomy (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5800 |