Submission Details
| 510(k) Number | K203749 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable
May 2021
Decision
131d
Days
Class 2
Risk
About This 510(k) Submission
K203749 is an FDA 510(k) clearance for the Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable, 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 review panel. Regulated under 21 CFR 868.5740.
Device Classification
| Product Code | CBI — Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5740 |
Manufacturer
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