MNT
- Product code
- MNT
- Device name
- Sv70 Ventilator
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5895
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 25
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252182 | 2026-04-06 | Shenzhen Mindray Bio-Medical Electroni | SV70 Ventilator (SV70) | |
| K242931 | 2025-05-15 | Mekics Co., Ltd. | HFT750U | FDA |
| K240779 | 2024-12-13 | Breas Medical AB | Vivo 3 | FDA |
| K233643 | 2024-08-09 | Fisher & Paykel Healthcare, Ltd. | F&P Airvo 3 NIV (PT311US) |
Official FDA classification page: MNT
Classification and pathway per current FDA publications. Data from openFDA (CC0).