vatech A9 (Model : PHT-30CSS)— 510(k) K203797

Substantially Equivalent

VATECH Co., Ltd.

FDA 510(k) clearance K203797 for vatech A9 (Model : PHT-30CSS), Substantially Equivalent on 2021-01-25. Applicant: VATECH Co., Ltd.. Device class: 2.

Clearance details

Applicant: VATECH Co., Ltd.
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2020-12-28
Decision date: 2021-01-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Hwaseong-Si, 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.