FDA 510(k)

ERI 手持式牙科X射线系统（型号AG100）

K号: K213282 · 2022-04-04

申请人Energy Resources International Co., Ltd. Hsinchu Branch

决定日期2022-04-04

产品代码EHD

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决定实质等同

器械摘要

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

常见问题

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. The listed applicant is Energy Resources International Co., Ltd. Hsinchu Branch. The 510(k) number is K213282.

When did ERI Handheld Dental X-ray System (Model AG100) receive FDA 510(k) clearance?

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

Who is the listed applicant for ERI Handheld Dental X-ray System (Model AG100)?

The FDA 510(k) record lists Energy Resources International Co., Ltd. Hsinchu Branch as the applicant. This does not by itself establish the device manufacturer.

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.

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

ERI 手持式牙科X射线系统（型号AG100）

器械摘要

常见问题

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