K110631 is an FDA 510(k) clearance for the VENNER TRACHEAL SEAL MONITOR. This device is classified as a Cuff, Tracheal Tube, Inflatable (Class II - Special Controls, product code BSK).
Submitted by Venner Medical (Singapore) Pte, Ltd. (Rockville, US). The FDA issued a Cleared decision on July 28, 2011, 146 days after receiving the submission on March 4, 2011.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5750.
| 510(k) Number | K110631 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2011 |
| Decision Date | July 28, 2011 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BSK - Cuff, Tracheal Tube, Inflatable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5750 |