FDA 510(k) Application Details - K231107

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K231107
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	Hunan Endoso Life Technology Co., Ltd. 4th floor, Building 10, Innovation and Entrepreneurship Center, 31 Dongfeng Road, Heping Street Xiangtan 411199 CN Other 510(k) Applications for this Company
Contact	Fu Wang 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	04/19/2023
Decision Date	02/15/2024
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