K152778 is an FDA 510(k) clearance for the TRACOE Cuff Pressure Monitor. This device is classified as a Cuff, Tracheal Tube, Inflatable (Class II - Special Controls, product code BSK).
Submitted by Tracoe Medical GmbH (Nieder-Olm, DE). The FDA issued a Cleared decision on December 21, 2016, 453 days after receiving the submission on September 25, 2015.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5750.
| 510(k) Number | K152778 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2015 |
| Decision Date | December 21, 2016 |
| Days to Decision | 453 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 |