FDA 510(k) Application Details - K213635

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K213635
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	Hunan Vathin Medical Instrument Co., Ltd. 1/F, Building 12, No.9 Chuanqi West Road, Jiuhua Economic Development Zone Xiangtan 411100 CN Other 510(k) Applications for this Company
Contact	Feng Yun 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	11/17/2021
Decision Date	02/28/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review