510(k) K243767 ยท CBK Ventilator, Continuous, Facility Use
SV600, SV800 Ventilator
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Aug 28, 2025 |
| Received | Dec 6, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243767
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.