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FDA 510(k)

QardioCore

K-Number: K201644 · 2021-02-28

ApplicantQardio, Inc.
Decision Date2021-02-28
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QardioCore is a medical device manufactured by Qardio, Inc.. It received FDA 510(k) clearance on 2021-02-28 under approval number K201644. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QardioCore?

QardioCore is a medical device that received FDA 510(k) clearance on 2021-02-28. It is manufactured by Qardio, Inc.. The 510(k) number is K201644.

When was QardioCore approved by the FDA?

QardioCore received FDA 510(k) clearance on 2021-02-28, under approval number K201644.

What company makes QardioCore?

QardioCore is manufactured by Qardio, Inc..

What is the FDA product code for QardioCore?

The FDA product code for QardioCore is DSH.

Other Devices by Qardio, Inc.

K220106QardioArm 2

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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.

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