K102824 is an FDA 510(k) clearance for the AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC. This device is classified as a Ventilator, Emergency, Manual (resuscitator) (Class II - Special Controls, product code BTM).
Submitted by Ambu A/S (Glen Burnie, US). The FDA issued a Cleared decision on January 28, 2011, 121 days after receiving the submission on September 29, 2010.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5915.
| 510(k) Number | K102824 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2010 |
| Decision Date | January 28, 2011 |
| Days to Decision | 121 days |
| Submission Type | Abbreviated |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTM — Ventilator, Emergency, Manual (resuscitator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5915 |