Vivo 3

FDA 510(k) K240779 · Breas Medical AB

Substantially Equivalent

510(k) numberK240779

Submission

Device name
Vivo 3
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
MNT – Sv70 Ventilator
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5895
Specialty
Anesthesiology
Life-sustaining
Yes

Other 510(k)s with product code MNT

510(k)DeviceApplicantDecision
K252182SV70 Ventilator (SV70)MNT · Traditional Shenzhen Mindray Bio-Medical Electronics Co., Ltd.04/06/2026SE
K242931HFT750UMNT · Traditional Mekics Co., Ltd.05/15/2025SE
K233643F&P Airvo 3 NIV (PT311US)MNT · Traditional Fisher & Paykel Healthcare, Ltd.08/09/2024SE
K230173Servo-air Lite Ventilator SystemMNT · Traditional Maquet Critical Care AB07/06/2023SE
K213521Nihon Kohden NKV-330 Ventilator SystemMNT · Traditional Nihon Kohden Orangemed, Inc.07/01/2022SE
K191624F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve VersionMNT · Traditional Fisher & Paykel Healthcare Limited03/09/2020SE
K170367Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large…MNT · Traditional Fisher and Paykel Healthcare Limited08/24/2017SE
K122715Stellar 150MNT · Traditional Resmed Germany, Inc.06/17/2013SE
K121623BIPAP a 40 Ventilatory Support SystemMNT · Abbreviated Respironics, Inc.12/14/2012SE
K113640Stellar 150MNT · Traditional Resmed Germany, Inc.04/05/2012SE

More from Resmed Germany, Inc.

510(k)DeviceDecision
K242485EveryWareMOD · Traditional 05/20/2025SE
K242438ClearoNHJ · Traditional 05/16/2025SE
K233452Vivo 45 LSNOU · Traditional 01/13/2025SE
K240778Vivo 1, Vivo 2MNS · 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 3 cleared by the FDA?

Vivo 3 (K240779) 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 K240779?

The FDA product code is MNT – Sv70 Ventilator, a Class II (moderate risk) device regulated under 21 CFR 868.5895.