510(k) K192177 ยท BZD Ventilator, Non-Continuous (Respirator)
SysMed S/T
| Applicant | Sysmed (China) Co., Ltd., Shenyang, CN |
| Decision | Substantially Equivalent, Nov 25, 2020 |
| Received | Aug 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192177
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.