EzRay Air Portable (Model: VEX-P300)— 510(k) K200182

Name: FDA 510(k) clearance K200182
Creator: U.S. Food and Drug Administration
Published: 2020-02-11

Substantially Equivalent

VATECH Co., Ltd.

FDA 510(k) clearance K200182 for EzRay Air Portable (Model: VEX-P300), Substantially Equivalent on 2020-02-11. 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: 2020-01-24
Decision date: 2020-02-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

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