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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 K243219
Device Name MONARCH™ Platform (MON-000008)
Applicant
Auris Health, Inc.
5490 Great America Pkwy.
Santa Clara,  CA  94054
Applicant Contact Amy Clendening-Wheeler
Correspondent
Auris Health, Inc.
5490 Great America Pkwy.
Santa Clara,  CA  94054
Correspondent Contact Amy Clendening-Wheeler
Regulation Number874.4680
Classification Product Code
EOQ  
Subsequent Product Codes
JAK   QNW  
Date Received10/07/2024
Decision Date 01/23/2025
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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