K152931 is an FDA 510(k) clearance for the Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator. This device is classified as a Ventilator, Emergency, Manual (resuscitator) (Class II - Special Controls, product code BTM).
Submitted by Ambu A/S (Ballerup, DK). The FDA issued a Cleared decision on August 29, 2016, 329 days after receiving the submission on October 5, 2015.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5915.
| 510(k) Number | K152931 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 2015 |
| Decision Date | August 29, 2016 |
| Days to Decision | 329 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 |