FDA 510(k) Application Details - K243429

Device Classification Name	Endoscope, Neurological   More FDA Info for this Device
510(K) Number	K243429
Device Name	Endoscope, Neurological
Applicant	HJY Smart Medical Device Co., Ltd. 12F., No. 415, Sec. 4, Xinyi Rd., Xinyi Dist., Taipei 11051 TW Other 510(k) Applications for this Company
Contact	John Chen Other 510(k) Applications for this Contact
Regulation Number	882.1480   More FDA Info for this Regulation Number
Classification Product Code	GWG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2024
Decision Date	05/21/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review