FDA 510(k) Application Details - K230428

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K230428
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	Ambu A/S Baltorpbakken 13 Ballerup 2750 DK Other 510(k) Applications for this Company
Contact	Karina Matthiesen 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	02/17/2023
Decision Date	08/10/2023
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