EzRay Air 2 Wall (Model: VEX-S350W)— 510(k) K223058

Name: FDA 510(k) clearance K223058
Creator: U.S. Food and Drug Administration
Published: 2022-10-26

Substantially Equivalent

VATECH Co., Ltd.

FDA 510(k) clearance K223058 for EzRay Air 2 Wall (Model: VEX-S350W), Substantially Equivalent on 2022-10-26. Applicant: VATECH Co., Ltd.. Device class: 2.

Clearance details

Applicant: VATECH Co., Ltd.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2022-09-30
Decision date: 2022-10-26
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.