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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 K262214
Device Name Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)
Applicant
Guangzhou Aimooe Technology Co., Ltd.
Rm. 101, #30-6, Kaitai Ave., Huangpu District, 510700 Guangz
Guangzhou,  CN 510700
Applicant Contact Peifeng Guan
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
#1919-1920, Bldg. D3, Minjie Plz., Shuixi Rd., Huangpu Distr
Guangzhou,  CN 51000
Correspondent Contact Cassie Lee
Regulation Number882.4560
Classification Product Code
HAW  
Date Received06/30/2026
Decision Date 10/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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