K203749 is an FDA 510(k) clearance for the Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable. This device is classified as a Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (Class II - Special Controls, product code CBI).
Submitted by Ambu A/S (Ballerup, DK). The FDA issued a Cleared decision on May 3, 2021, 131 days after receiving the submission on December 23, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5740.
| 510(k) Number | K203749 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2020 |
| Decision Date | May 03, 2021 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBI — Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5740 |