K242931
- 510(k) number
- K242931
- Device name
- HFT750U
- Applicant
- Mekics Co., Ltd. KR
- Product code
- MNT — Sv70 Ventilator
- Decision date
- 2025-05-15
- Date received
- 2024-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
510(k) Summary (official FDA PDF): K242931.pdf
Official FDA record: K242931
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.