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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bronchoscope (flexible or rigid)
510(k) Number K173760
Device Name Monarch Endoscopy Platform (Monarch Platform)
Auris Surgical Robotics, Inc.
125 Shoreway Road
Suite D
San Carlos,  CA  94070
Applicant Contact Joy Sacmar
Auris Surgical Robotics, Inc.
150 Shoreline Drive
Redwood City,  CA  94065
Correspondent Contact Joy Sacmar
Regulation Number874.4680
Classification Product Code
Subsequent Product Code
Date Received12/11/2017
Decision Date 03/22/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls