FDA 510(k) Application Details - K211894

Device Classification Name	Bronchoscope Accessory   More FDA Info for this Device
510(K) Number	K211894
Device Name	Bronchoscope Accessory
Applicant	DISA Medinotec Stand 171, Northlands Business Park, Bush Telegraph Street Northriding Johannesburg 2169 ZA Other 510(k) Applications for this Company
Contact	Michelle Nieuwoudt 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	06/21/2021
Decision Date	11/24/2021
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