FDA 510(k) Application Details - K243219

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K243219
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	Auris Health, Inc. 5490 Great America Parkway Santa Clara, CA 94054 US Other 510(k) Applications for this Company
Contact	Amy Clendening-Wheeler 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	10/07/2024
Decision Date	01/23/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review