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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K223834
Device Name AccuCheck
Applicant
Manteia Technologies Co., Ltd.
1903, B Tower, Zijin Plaza, #1811 Huandao E. Rd.
Xiamen,  CN 361001
Applicant Contact Yingkai Lin
Correspondent
Manteia Technologies Co., Ltd.
1903, B Tower, Zijin Plaza, #1811 Huandao E. Rd.
Xiamen,  CN 361001
Correspondent Contact Chao Fang
Regulation Number892.5050
Classification Product Code
IYE  
Date Received12/22/2022
Decision Date 07/20/2023
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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