ERI Handheld Dental X-ray System (Model AG100)— 510(k) K213282

Name: FDA 510(k) clearance K213282
Creator: U.S. Food and Drug Administration
Published: 2022-04-04

Substantially Equivalent

Energy Resources International Co., Ltd. Hsinchu Branch

FDA 510(k) clearance K213282 for ERI Handheld Dental X-ray System (Model AG100), Substantially Equivalent on 2022-04-04. Applicant: Energy Resources International Co., Ltd. Hsinchu Branch. Device class: 2.

Clearance details

Applicant: Energy Resources International Co., Ltd. Hsinchu Branch
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2021-10-01
Decision date: 2022-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhubei City, TW

Download summary PDF View on FDA.gov ↗

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