Cleared Traditional

Vivo 45 LS

K233452 · Breas Medical AB · Anesthesiology
Jan 2025
Decision
451d
Days
Class 2
Risk

About This 510(k) Submission

K233452 is an FDA 510(k) clearance for the Vivo 45 LS, a Continuous, Ventilator, Home Use (Class II — Special Controls, product code NOU), submitted by Breas Medical AB (Molnlycke, SE). The FDA issued a Cleared decision on January 13, 2025, 451 days after receiving the submission on October 20, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K233452 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 2023
Decision Date January 13, 2025
Days to Decision 451 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code NOU — Continuous, Ventilator, Home Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895
Definition This Product Code Was Needed For The Home Use Indication. Cbk Is Not A Tracked Device And Nou Is A Tracked Device.