510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060546Substantially Equivalent

Breas Vivo Bilevel System, Model Vivo 30

Breas Medical AB, Molnlycke, Vastra Gotaland, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060546 is the FDA 510(k) clearance record for BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30, a class II device, cleared for Breas Medical AB on under FDA product code MNS (Ventilator, Continuous, Non-Life-Supporting). FDA records list 16 510(k) clearances for Breas Medical AB, from to . As of , FDA records show no recalls naming K060546.

Clearance record

Decision date
Received
(86 days to decision)
Product code
MNS Ventilator, Continuous, Non-Life-Supporting
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Breas Medical AB Foretagsvagen 1, Molnlycke, Vastra Gotaland, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MNS

Trailing 12 months
3 clearances under product code MNS in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MNS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260