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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 K211493
Device Name Monarch Platform
Applicant
Auris Health, Inc.
150 Shoreline Dr.
Redwood,  CA  94065
Applicant Contact Shikha Gola
Correspondent
Auris Health, Inc.
150 Shoreline Dr.
Redwood,  CA  94065
Correspondent Contact Shikha Gola
Regulation Number874.4680
Classification Product Code
EOQ  
Subsequent Product Code
JAK  
Date Received05/13/2021
Decision Date 07/09/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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