510(k) K233452 ยท NOU Continuous, Ventilator, Home Use
Vivo 45 LS
| Applicant | Breas Medical AB, Molnlycke, SE |
| Decision | Substantially Equivalent, Jan 13, 2025 |
| Received | Oct 20, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233452
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 27, 2023 | Breas Medical, Inc. with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS.
intended for partial insertion into a patient's mouth (in betw Open, Classified |
NOU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.