K203362 is an FDA 510(k) clearance for the TRACOE vario. This device is classified as a Tube Tracheostomy And Tube Cuff (Class II - Special Controls, product code JOH).
Submitted by Tracoe Medical GmbH (Nieder-Olm, DE). The FDA issued a Cleared decision on August 5, 2021, 262 days after receiving the submission on November 16, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K203362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2020 |
| Decision Date | August 05, 2021 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | JOH - Tube Tracheostomy And Tube Cuff |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5800 |