FDA 510(k) Application Details - K250232

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K250232
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	Hunan Vathin Medical Instrument Co., Ltd. 1/F, Building12, Innovation and Entrepreneurship Service Cen ter, No. 9 Chuanqi West Road, Jiuhua Economic Development Zo Xiang Tan 411100 CN Other 510(k) Applications for this Company
Contact	Jing Du 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	01/27/2025
Decision Date	07/25/2025
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