Cleared Traditional

Vivo 3

K240779 · Breas Medical AB · Anesthesiology
Dec 2024
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K240779 is an FDA 510(k) clearance for the Vivo 3, a Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (Class II — Special Controls, product code MNT), submitted by Breas Medical AB (Molnlycke, SE). The FDA issued a Cleared decision on December 13, 2024, 267 days after receiving the submission on March 21, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K240779 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2024
Decision Date December 13, 2024
Days to Decision 267 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MNT — Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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