510(k) K152931 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator
| Applicant | Ambu A/S, Ballerup, DK |
| Decision | Substantially Equivalent, Aug 29, 2016 |
| Received | Oct 5, 2015 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K152931
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2025 | Ambu Inc. Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Re Open, Classified |
BTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.