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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 K193534
Device Name Monarch Platform
Applicant
Auris Health, Inc.
150 Shoreline Drive
Redwood City,  CA  94065
Applicant Contact Anna Libman
Correspondent
Auris Health, Inc.
150 Shoreline Drive
Redwood City,  CA  94065
Correspondent Contact Anna Libman
Regulation Number874.4680
Classification Product Code
EOQ  
Subsequent Product Code
JAK  
Date Received12/20/2019
Decision Date 04/15/2020
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
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