FDA 510(k) Application Details - K202987

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K202987
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	Anrei Medical (Hangzhou) Co., Ltd No. 3 Ave 8, HEDA Hangzhou 310018 CN Other 510(k) Applications for this Company
Contact	Huibing Yang 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	09/30/2020
Decision Date	04/29/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review