Breas Vivo 40 System
FDA 510(k) K090113 · Breas Medical AB
510(k) numberK090113
Submission
- Device name
- Breas Vivo 40 System
- Applicant
- Breas Medical AB
Molnlycke, SE - Received
- January 21, 2009
- Decision date
- May 14, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNT – Sv70 Ventilator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K252182 | SV70 Ventilator (SV70)MNT · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 04/06/2026SE |
| K242931 | HFT750UMNT · Traditional | Mekics Co., Ltd. | 05/15/2025SE |
| K240779 | Vivo 3MNT · Traditional | Breas Medical AB | 12/13/2024SE |
| K233643 | F&P Airvo 3 NIV (PT311US)MNT · Traditional | Fisher & Paykel Healthcare, Ltd. | 08/09/2024SE |
| K230173 | Servo-air Lite Ventilator SystemMNT · Traditional | Maquet Critical Care AB | 07/06/2023SE |
| K213521 | Nihon Kohden NKV-330 Ventilator SystemMNT · Traditional | Nihon Kohden Orangemed, Inc. | 07/01/2022SE |
| K191624 | F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve VersionMNT · Traditional | Fisher & Paykel Healthcare Limited | 03/09/2020SE |
| K170367 | Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large…MNT · Traditional | Fisher and Paykel Healthcare Limited | 08/24/2017SE |
| K122715 | Stellar 150MNT · Traditional | Resmed Germany, Inc. | 06/17/2013SE |
| K121623 | BIPAP a 40 Ventilatory Support SystemMNT · Abbreviated | Respironics, Inc. | 12/14/2012SE |
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| 510(k) | Device | Decision |
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| K242485 | EveryWareMOD · Traditional | 05/20/2025SE |
| K242438 | ClearoNHJ · Traditional | 05/16/2025SE |
| K233452 | Vivo 45 LSNOU · Traditional | 01/13/2025SE |
| K240779 | Vivo 3MNT · Traditional | 12/13/2024SE |
| K240778 | Vivo 1, Vivo 2MNS · Traditional | 12/13/2024SE |
| K193586 | Vivo 45 LSNOU · Traditional | 01/27/2021SE |
| K160481 | Vivo 60NOU · Traditional | 11/09/2016SE |
| K071702 | Breas Vivo Bilevel System, Model Vivo 40MNT · Traditional | 02/15/2008SE |
| K063476 | Breas Isleep 20IBZD · Special | 01/22/2007SE |
| K060657 | Isleep by Breas, Models Isleep 10, Isleep 20.BZD · Special | 08/18/2006SE |
Questions and answers
When was Breas Vivo 40 System cleared by the FDA?
Breas Vivo 40 System (K090113) received a 510(k) decision of Substantially Equivalent on May 14, 2009, 113 days after the submission was received.
What is the product code of K090113?
The FDA product code is MNT – Sv70 Ventilator, a Class II (moderate risk) device regulated under 21 CFR 868.5895.