FDA 510(k) Application Details - K243289

Device Classification Name	More FDA Info for this Device
510(K) Number	K243289
Device Name	ADDNOX (BPSPM1)
Applicant	Nu Eyne Co., Ltd. #608, 28, Digital-ro 30-gil, Guro-gu Seoul 08389 KR Other 510(k) Applications for this Company
Contact	Dahee Kim Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QGL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/2024
Decision Date	01/16/2025
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