K053140 is an FDA 510(k) clearance for the AMBU MARK IV RESUSCITATOR. 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 December 23, 2005, 44 days after receiving the submission on November 9, 2005.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5915.
| 510(k) Number | K053140 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2005 |
| Decision Date | December 23, 2005 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| 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 |