MONARCH Platform (MON-000008)
K-Number: K243219 · 2025-01-23
ApplicantAuris Health, Inc.
Decision Date2025-01-23
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
MONARCH Platform (MON-000008) is a medical device manufactured by Auris Health, Inc.. It received FDA 510(k) clearance on 2025-01-23 under approval number K243219. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MONARCH Platform (MON-000008)?
MONARCH Platform (MON-000008) is a medical device that received FDA 510(k) clearance on 2025-01-23. It is manufactured by Auris Health, Inc.. The 510(k) number is K243219.
When was MONARCH Platform (MON-000008) approved by the FDA?
MONARCH Platform (MON-000008) received FDA 510(k) clearance on 2025-01-23, under approval number K243219.
What company makes MONARCH Platform (MON-000008)?
MONARCH Platform (MON-000008) is manufactured by Auris Health, Inc..
What is the FDA product code for MONARCH Platform (MON-000008)?
The FDA product code for MONARCH Platform (MON-000008) is EOQ.
Related Clinical Trials
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.