Monarch Platform
K-Number: K193534 · 2020-04-15
ApplicantAuris Health, Inc.
Decision Date2020-04-15
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Monarch Platform is a medical device manufactured by Auris Health, Inc.. It received FDA 510(k) clearance on 2020-04-15 under approval number K193534. 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?
Monarch Platform is a medical device that received FDA 510(k) clearance on 2020-04-15. It is manufactured by Auris Health, Inc.. The 510(k) number is K193534.
When was Monarch Platform approved by the FDA?
Monarch Platform received FDA 510(k) clearance on 2020-04-15, under approval number K193534.
What company makes Monarch Platform?
Monarch Platform is manufactured by Auris Health, Inc..
What is the FDA product code for Monarch Platform?
The FDA product code for Monarch Platform is EOQ.
Related Clinical Trials
Other Devices by Auris Health, Inc.
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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.