CardioGraphe
K-Number: K213465 · 2022-12-02
ApplicantArineta , Ltd.
Decision Date2022-12-02
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
CardioGraphe is a medical device manufactured by Arineta , Ltd.. It received FDA 510(k) clearance on 2022-12-02 under approval number K213465. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CardioGraphe?
CardioGraphe is a medical device that received FDA 510(k) clearance on 2022-12-02. It is manufactured by Arineta , Ltd.. The 510(k) number is K213465.
When was CardioGraphe approved by the FDA?
CardioGraphe received FDA 510(k) clearance on 2022-12-02, under approval number K213465.
What company makes CardioGraphe?
CardioGraphe is manufactured by Arineta , Ltd..
What is the FDA product code for CardioGraphe?
The FDA product code for CardioGraphe is JAK.
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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.