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FDA 510(k)

ERI Handheld Dental X-ray System (Model AG100)

K-Number: K213282 · 2022-04-04

ApplicantEnergy Resources International Co., Ltd. Hsinchu Branch
Decision Date2022-04-04
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ERI Handheld Dental X-ray System (Model AG100) is a medical device manufactured by Energy Resources International Co., Ltd. Hsinchu Branch. It received FDA 510(k) clearance on 2022-04-04 under approval number K213282. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERI Handheld Dental X-ray System (Model AG100)?

ERI Handheld Dental X-ray System (Model AG100) is a medical device that received FDA 510(k) clearance on 2022-04-04. It is manufactured by Energy Resources International Co., Ltd. Hsinchu Branch. The 510(k) number is K213282.

When was ERI Handheld Dental X-ray System (Model AG100) approved by the FDA?

ERI Handheld Dental X-ray System (Model AG100) received FDA 510(k) clearance on 2022-04-04, under approval number K213282.

What company makes ERI Handheld Dental X-ray System (Model AG100)?

ERI Handheld Dental X-ray System (Model AG100) is manufactured by Energy Resources International Co., Ltd. Hsinchu Branch.

What is the FDA product code for ERI Handheld Dental X-ray System (Model AG100)?

The FDA product code for ERI Handheld Dental X-ray System (Model AG100) is EHD.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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