FDA 510(k) Application Details - K232991

Device Classification Name	More FDA Info for this Device
510(K) Number	K232991
Device Name	BT-1000
Applicant	Bistos Co., Ltd. 7th Fl., A Bldg., Woolim Lions Valley 5-Cha, 302 Galmachi-Ro, Jungwon-Gu, Seongnam Gyeonggi 13201 KR Other 510(k) Applications for this Company
Contact	Goeun Choi 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	09/22/2023
Decision Date	08/28/2024
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