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FDA 510(k) Application Details - K223047
Device Classification Name
Nystagmograph
More FDA Info for this Device
510(K) Number
K223047
Device Name
Nystagmograph
Applicant
Neurobit Technologies Co., Ltd.
2F, No. 320 Sec 4, Zhongxiao E. Rd.
Taipei 10694 TW
Other 510(k) Applications for this Company
Contact
Chun-Chen Yang
Other 510(k) Applications for this Contact
Regulation Number
882.1460
More FDA Info for this Regulation Number
Classification Product Code
GWN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2022
Decision Date
06/29/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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