Vivo 1, Vivo 2

FDA 510(k) K240778 · Breas Medical AB

Substantially Equivalent

510(k) numberK240778

Submission

Device name
Vivo 1, Vivo 2
Applicant
Breas Medical AB
Molnlycke, SE
Received
March 21, 2024
Decision date
December 13, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MNS – Ventilator, Continuous, Non-Life-Supporting
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5895
Specialty
Anesthesiology

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K240779Vivo 3MNT · Traditional 12/13/2024SE
K193586Vivo 45 LSNOU · Traditional 01/27/2021SE
K160481Vivo 60NOU · Traditional 11/09/2016SE
K090113Breas Vivo 40 SystemMNT · Traditional 05/14/2009SE
K071702Breas Vivo Bilevel System, Model Vivo 40MNT · Traditional 02/15/2008SE
K063476Breas Isleep 20IBZD · Special 01/22/2007SE
K060657Isleep by Breas, Models Isleep 10, Isleep 20.BZD · Special 08/18/2006SE

Questions and answers

When was Vivo 1, Vivo 2 cleared by the FDA?

Vivo 1, Vivo 2 (K240778) received a 510(k) decision of Substantially Equivalent on December 13, 2024, 267 days after the submission was received.

What is the product code of K240778?

The FDA product code is MNS – Ventilator, Continuous, Non-Life-Supporting, a Class II (moderate risk) device regulated under 21 CFR 868.5895.