K110962 is an FDA 510(k) clearance for the AMBU ASCOPE 2. This device is classified as a Tube, Tracheal (w/wo Connector) (Class II - Special Controls, product code BTR).
Submitted by Ambu A/S (Glen Burnie, US). The FDA issued a Cleared decision on November 18, 2011, 226 days after receiving the submission on April 6, 2011.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5730.
| 510(k) Number | K110962 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2011 |
| Decision Date | November 18, 2011 |
| Days to Decision | 226 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTR — Tube, Tracheal (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5730 |