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FDA 510(k) Applications Submitted by Auris Health, Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K243219
10/07/2024
MONARCHÖ Platform (MON-000008)
Auris Health, Inc.
K193534
12/20/2019
Monarch Platform
Auris Health, Inc.
K211493
05/13/2021
Monarch Platform
Auris Health, Inc.
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