510(k) K232365 ยท CBK Ventilator, Continuous, Facility Use
Vivo 45 LS
| Applicant | Oconnell Regulatory Consultants, Inc., Stoneham MA, US |
| Decision | Substantially Equivalent, Dec 19, 2025 |
| Received | Aug 7, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232365
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.