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