Vivo 60— 510(k) K160481
Substantially EquivalentBreas Medical AB
FDA 510(k) clearance K160481 for Vivo 60, Substantially Equivalent on 2016-11-09. 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 Vastra Gotalands Lan, 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 K160481
K-number listed on FDA's recall record- Z-1352-2020 — 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 for additional protection of the Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilators during transportation, and in hospital, institutional, and home care environments. It can be used while the Vivo ventilators is operating, for example mounted on a wheelchair, in a personal vehicle, or carried by hand. The device is not to be used with the protective cover while positioned in a warm place, such as in direct sunlight or close to a radiator. The protective cover includes the following features: transparent window for accessing front panel and buttons; port for patient circuit, cables, O2 inlet, and standby button; cooling air inlet; patient air inlet; straps for safe mounting; and cooling air outlet.
- Z-2530-2018 — 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
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160481.
Data sourced from openFDA. This site is unofficial and independent of the FDA.