RUS— 510(k) K233457

Substantially Equivalent

Hutom, Inc.

FDA 510(k) clearance K233457 for RUS, Substantially Equivalent on 2024-07-12. Applicant: Hutom, Inc.. Device class: 2.

Clearance details

Applicant: Hutom, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2023-10-20
Decision date: 2024-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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