MNS
- Product code
- MNS
- Device name
- Ventilator, Continuous, Non-Life-Supporting
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5895
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 47 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251889 | 2026-04-08 | Resmed Corp | myAir | |
| K252078 | 2026-03-17 | Compal Electronics, Inc. | BreathePal Bilevel (GFM50-MD2201) | |
| K251661 | 2026-02-23 | Resmed Pty , Ltd. | Mariana Minerva; Mariana Nimbus | |
| K240778 | 2024-12-13 | Breas Medical AB | Vivo 1, Vivo 2 | FDA |
Official FDA classification page: MNS
Classification and pathway per current FDA publications. Data from openFDA (CC0).