VIVO 50— 510(k) K123144

Name: FDA 510(k) clearance K123144
Creator: U.S. Food and Drug Administration
Published: 2013-06-18

Substantially Equivalent

Ge Healthcare, Breas Medical AB

FDA 510(k) clearance K123144 for VIVO 50, Substantially Equivalent on 2013-06-18. Applicant: Ge Healthcare, Breas Medical AB. Device class: 2.

Clearance details

Applicant: Ge Healthcare, Breas Medical AB
Product code: Code NOU
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 2012-10-05
Decision date: 2013-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Molnlycke, SE

Download summary PDF View on FDA.gov ↗

Recent devices under product code NOU

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K034032 — PLV CONTINUUM VENTILATOR, MODEL P20002004-03-16
K022750 — PLV CONTINUUM VENTILATOR, MODEL P10002003-11-20

Adverse events under product code NOU

product code NOU

Death: 65
Injury: 138
Malfunction: 3,664
Other: 1
Total: 3,868

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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 K123144

K-number listed on FDA's recall record

Z-2094-2015 — Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory CareClass II·Terminated·Breas Medical AB·20141107

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123144.

Data sourced from openFDA. This site is unofficial and independent of the FDA.