Arterys MICA
K-Number: K203744 · 2022-03-14
ApplicantArterys, Inc.
Decision Date2022-03-14
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Arterys MICA is a medical device manufactured by Arterys, Inc.. It received FDA 510(k) clearance on 2022-03-14 under approval number K203744. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Arterys MICA?
Arterys MICA is a medical device that received FDA 510(k) clearance on 2022-03-14. It is manufactured by Arterys, Inc.. The 510(k) number is K203744.
When was Arterys MICA approved by the FDA?
Arterys MICA received FDA 510(k) clearance on 2022-03-14, under approval number K203744.
What company makes Arterys MICA?
Arterys MICA is manufactured by Arterys, Inc..
What is the FDA product code for Arterys MICA?
The FDA product code for Arterys MICA is QIH.
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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.