510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193586Substantially Equivalent

Vivo 45 LS

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

K193586 is the FDA 510(k) clearance record for Vivo 45 LS, a class II device, cleared for Breas Medical AB on under FDA product code NOU (Continuous, Ventilator, Home Use). FDA's definition for product code NOU reads: "This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device". FDA records list 16 510(k) clearances for Breas Medical AB, from to . As of , FDA records show 3 recalls naming K193586.

Clearance record

Decision date
Received
(401 days to decision)
Product code
NOU Continuous, Ventilator, Home Use
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Breas Medical AB Foretagsvagen 1, Molnlycke, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NOU

Trailing 12 months

FDA records hold no clearances under product code NOU in the trailing twelve months.

FDA records show no clearances under product code NOU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NOU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260