510(k) K210288 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
Disposable Manual Resuscitator
| Applicant | Xiamen Compower Medical Tech. Co., Ltd., Xiamen, CN |
| Decision | Substantially Equivalent, Aug 26, 2021 |
| Received | Feb 2, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210288
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.