FDA 510(k) Application Details - K213060

Device Classification Name	Bronchoscope Accessory   More FDA Info for this Device
510(K) Number	K213060
Device Name	Bronchoscope Accessory
Applicant	Micro-Tech (Nanjing) Co., Ltd. No. 10 Gaoke Third Road, Nanjing National Hi-tech Industrial Development Zone Nanjing 210032 CN Other 510(k) Applications for this Company
Contact	Sally He Other 510(k) Applications for this Contact
Regulation Number	874.4680   More FDA Info for this Regulation Number
Classification Product Code	KTI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/22/2021
Decision Date	07/20/2022
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