FDA 510(k) Application Details - K210379

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K210379
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	Scivita Medical Technology Co., Ltd. No.8, ZhongTian Xiang, Suzhou Industrial Park Suzhou 215000 CN Other 510(k) Applications for this Company
Contact	Ruqin Wu 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	02/09/2021
Decision Date	07/28/2021
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