FDA 510(k) Application Details - K232582

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K232582
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	Ambu A/S Baltorpbakken 13 Ballerup 2750 DK Other 510(k) Applications for this Company
Contact	Eva Lind Rasmussen 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	08/25/2023
Decision Date	09/20/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review