510(k) K160481 ยท NOU Continuous, Ventilator, Home Use
Vivo 60
| Applicant | Breas Medical AB, Molnlycke Vastra Gotalands Lan, SE |
| Decision | Substantially Equivalent, Nov 9, 2016 |
| Received | Feb 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160481
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2020 | Breas Medical, Inc. Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended Terminated |
NOU | None listed |
| May 8, 2018 | Human Design Medical Llc Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000
Product Usage:
To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Terminated |
NOU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.