510(k) K193586 ยท NOU Continuous, Ventilator, Home Use
Vivo 45 LS
| Applicant | Breas Medical AB, Molnlycke, SE |
| Decision | Substantially Equivalent, Jan 27, 2021 |
| Received | Dec 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193586
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2024 | Breas Medical, Inc. Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Open, Classified |
NOU | None listed |
| 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 |
| Jun 2, 2022 | Breas Medical, Inc. Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation
Model Number: 230000
If the recalled product Open, Classified |
NOU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.