FDA 510(k) Application Details - K222861

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K222861
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	Olympus Medical Systems Corporation 2951 Ishikawa-cho Hachioji-shi Tokyo 192-8507 JP Other 510(k) Applications for this Company
Contact	Shinichiro Kawachi 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	09/22/2022
Decision Date	06/15/2023
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