Huvitz Imaging System— 510(k) K191615

Substantially Equivalent

Huvitz Co., Ltd.

FDA 510(k) clearance K191615 for Huvitz Imaging System, Substantially Equivalent on 2019-07-18. Applicant: Huvitz Co., Ltd.. Device class: 2.

Clearance details

Applicant: Huvitz Co., Ltd.
Product code: Code NFJ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2019-06-18
Decision date: 2019-07-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Anyang-Si, Dongan-Gu, 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.