FDA 510(k) Application Details - K231473

Device Classification Name	More FDA Info for this Device
510(K) Number	K231473
Device Name	Monarch Bronchoscope
Applicant	Auris Health Inc., a Johnson and Johnson Family Company 150 Shoreline Drive Redwood City, CA 94065 US Other 510(k) Applications for this Company
Contact	Somi Ekwealor Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/2023
Decision Date	11/28/2023
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