FDA 510(k) Application Details - K242793

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K242793
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	Shenzhen Insighters Medical Technology Co., Ltd. The 13th floor of Hengtemei Building, Ganli Road No.3 Shenzhen 518000 CN Other 510(k) Applications for this Company
Contact	Baohong Fang 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	09/16/2024
Decision Date	05/28/2025
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