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..

Clearance details

Applicant: Huvitz Co., Ltd.
Product code: Code NFJ
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

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