HFT750U— 510(k) K242931

Substantially Equivalent

Mekics Co., Ltd.

FDA 510(k) clearance K242931 for HFT750U, Substantially Equivalent on 2025-05-15. Applicant: Mekics Co., Ltd..

Clearance details

Applicant: Mekics Co., Ltd.
Product code: Code MNT
Advisory panel: Anesthesiology
Date received: 2024-09-25
Decision date: 2025-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNT

product code MNT

Death: 118
Injury: 324
Malfunction: 25,451
Other: 2
Total: 25,895

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.