K093186 is an FDA 510(k) clearance for the AMBU ASCOPE AND MONITOR. 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 April 16, 2010, 189 days after receiving the submission on October 9, 2009.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5730.
| 510(k) Number | K093186 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2009 |
| Decision Date | April 16, 2010 |
| Days to Decision | 189 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 |