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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nystagmograph
510(k) Number K223047
Device Name NeuroSwift Pro
Applicant
Neurobit Technologies Co., Ltd.
2f, # 320 Sec 4, Zhongxiao E. Rd.
Taipei,  TW 10694
Applicant Contact Chun-Chen Yang
Correspondent
Intellrac Consulting , Ltd.
1 F., # 28, Ln. 18, Shude 1st. St., Taiping Dist.
Taichung City,  TW 411
Correspondent Contact Tyra Chiu
Regulation Number882.1460
Classification Product Code
GWN  
Date Received09/29/2022
Decision Date 06/29/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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