FDA 510(k) Application Details - K222187

Device Classification Name	Bronchoscope Accessory   More FDA Info for this Device
510(K) Number	K222187
Device Name	Bronchoscope Accessory
Applicant	Dongguan TT Medical, Inc. BLD#1, 1 Taoyuan Road, Songshan Lake Dongguan 523808 CN Other 510(k) Applications for this Company
Contact	Yuying Bi 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	07/22/2022
Decision Date	03/01/2023
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