FDA 510(k) Application Details - K193534

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K193534
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	Auris Health, Inc. 150 Shoreline Drive Redwood City, CA 94065 US Other 510(k) Applications for this Company
Contact	Anna Libman 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	12/20/2019
Decision Date	04/15/2020
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