FDA · official record K213282Substantially Equivalent

ERI Handheld Dental X-ray System (Model AG100)

Name: ERI Handheld Dental X-ray System (Model AG100) — FDA K213282
Creator: Energy Resources International Co., Ltd. Hsinchu Branch
Keywords: ERI Handheld Dental X-ray System (Model AG100), ERI Handheld Dental X-ray System (Model AG100), K213282, EHD, FDA

United StatesEHDEnergy Resources International Co., Ltd. Hsinchu Branch

Verified

Official record identity

FDA application number: K213282
Decision date: April 04, 2022
Published decision: Substantially Equivalent

Classification

Product code: EHD

Published parties

Applicant: Energy Resources International Co., Ltd. Hsinchu Branch

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2021-10-01
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.1800

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.