FDA 510(k) Application Details - K233779

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K233779
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	MacroLux Medical Technology Co., Ltd. 301, Building 3, NamTai Inno Park In Guang Ming Avenue, Guangming Shenzhen 518107 CN Other 510(k) Applications for this Company
Contact	Linbin Ye Other 510(k) Applications for this Contact
Regulation Number	874.4680   More FDA Info for this Regulation Number
Classification Product Code	EOQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/27/2023
Decision Date	04/05/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review