FDA 510(k) Application Details - K211493

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K211493
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	Auris Health, Inc. 150 Shoreline Drive Redwood, CA 94065 US Other 510(k) Applications for this Company
Contact	Shikha Gola 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	05/13/2021
Decision Date	07/09/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review