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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mobile
510(k) Number K234108
Device Name ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)
Applicant
Energy Resources International Co., Ltd.
2f.-5, #6-1, Sec.2, Shengyi Rd., Zhubei City
Hsinchu County,  TW 302058
Applicant Contact Pearl Tsai
Correspondent
Energy Resources International Co., Ltd.
2f.-5, #6-1, Sec.2, Shengyi Rd., Zhubei City
Hsinchu County,  TW 302058
Correspondent Contact Pearl Tsai
Regulation Number892.1720
Classification Product Code
IZL  
Date Received12/27/2023
Decision Date 09/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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