Clever One— 510(k) K250005

Substantially Equivalent

Ewoosoft Co., Ltd.

FDA 510(k) clearance K250005 for Clever One, Substantially Equivalent on 2025-05-23. Applicant: Ewoosoft Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ewoosoft Co., Ltd.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-01-02
Decision date: 2025-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Ewoosoft Co., Ltd.

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