Vivo 45 LS— 510(k) K193586
Substantially EquivalentBreas Medical AB
FDA 510(k) clearance K193586 for Vivo 45 LS, Substantially Equivalent on 2021-01-27. Applicant: Breas Medical AB. Device class: 2.
Clearance details
- Applicant
- Breas Medical AB
- Product code
- Code NOU
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Molnlycke, SE
Recent devices under product code NOU
view allMore clearances from Breas Medical AB
view allAdverse events under product code NOU
product code NOU- Death
- 65
- Injury
- 138
- Malfunction
- 3,664
- Other
- 1
- Total
- 3,868
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K193586
K-number listed on FDA's recall record- Z-2690-2024 — 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 Number: 230000 (230016, 230216)
- Z-0405-2024 — 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 between the lips) to facilitate access to the respiratory system.
- Z-1382-2022 — 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 is a software, include version number: firmware versions 5.0.5 or earlier
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193586.
Data sourced from openFDA. This site is unofficial and independent of the FDA.