Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Nystagmograph
510(k) Number K223047
Device Name NeuroSwift Pro
Applicant
Neurobit Technologies Co., Ltd.
2F, No. 320 Sec 4, Zhongxiao E. Rd.
Taipei,  TW 10694
Applicant Contact Chun-Chen Yang
Correspondent
Intellrac Consulting Ltd.
1 F., No. 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
-
-