QardioArm 2
K-Number: K220106 · 2022-06-15
ApplicantQardio, Inc.
Decision Date2022-06-15
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
QardioArm 2 is a medical device manufactured by Qardio, Inc.. It received FDA 510(k) clearance on 2022-06-15 under approval number K220106. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the QardioArm 2?
QardioArm 2 is a medical device that received FDA 510(k) clearance on 2022-06-15. It is manufactured by Qardio, Inc.. The 510(k) number is K220106.
When was QardioArm 2 approved by the FDA?
QardioArm 2 received FDA 510(k) clearance on 2022-06-15, under approval number K220106.
What company makes QardioArm 2?
QardioArm 2 is manufactured by Qardio, Inc..
What is the FDA product code for QardioArm 2?
The FDA product code for QardioArm 2 is DXN.
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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.