MINE ALNU (Model: Mine 2.1)— 510(k) K213405

Name: FDA 510(k) clearance K213405
Creator: U.S. Food and Drug Administration
Published: 2022-07-10

Substantially Equivalent

Hdt Co., Ltd.

FDA 510(k) clearance K213405 for MINE ALNU (Model: Mine 2.1), Substantially Equivalent on 2022-07-10. Applicant: Hdt Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hdt Co., Ltd.
Product code: Code IZL
Device class: Class 2
Regulation: 21 CFR 892.1720
Advisory panel: Radiology
Date received: 2021-10-19
Decision date: 2022-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gwangju, KR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

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.