Green16/Green18 (Model: PHT-65LHS)— 510(k) K170066

Name: FDA 510(k) clearance K170066
Creator: U.S. Food and Drug Administration
Published: 2017-06-16

Substantially Equivalent

VATECH Co., Ltd.

FDA 510(k) clearance K170066 for Green16/Green18 (Model: PHT-65LHS), Substantially Equivalent on 2017-06-16. 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: 2017-01-09
Decision date: 2017-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
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.