FDA 510(k) Application Details - K250210

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K250210
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	Scivita Medical Technology Co.,Ltd. No.2, Qingqiu Street, Suzhou Industrial Park Suzhou 215000 CN Other 510(k) Applications for this Company
Contact	Wu Ruqin 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	01/24/2025
Decision Date	03/19/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review