HFT750U
FDA 510(k) clearance K242931 · decided 2025-05-15
Clearance details
- K-number
- K242931
- Device name
- HFT750U
- Applicant
- Mekics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-25
- Decision date
- 2025-05-15
- Days to decision
- 232 days
- Clearance type
- Traditional
- Product code
- MNT
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Gyeonggi-Do, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.