FDA 510(k) Application Details - K152319

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K152319
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	AURIS SURGICAL ROBOTICS, INC. 125 SHOREWAY ROAD, SUITE D SAN CARLOS, CA 94070 US Other 510(k) Applications for this Company
Contact	MICHAEL A. DANIEL 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	08/17/2015
Decision Date	05/26/2016
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