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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name neurological stereotaxic instrument
510(k) Number K220072
Device Name Sinobot X1
Applicant
Sinovation (Beijing) Medical Technology Co., Ltd
Rm 401, Bld 12-1, No.26 Yongwang West Road, Z-park
Daxing
Beijing,  CN 102600
Applicant Contact Manman Xu
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road, Building 1, Suite 300
Austin,  TX  78746
Correspondent Contact Giselle Zhang
Regulation Number882.4560
Classification Product Code
HAW  
Date Received01/10/2022
Decision Date 06/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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