FDA 510(k)

QardioCore

K-Number: K201644 · 2021-02-28

Decision Date2021-02-28

Product CodeDSH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

QardioCore is the device name listed in this FDA 510(k) record. The listed applicant is Qardio, Inc.. It received FDA 510(k) clearance on 2021-02-28 under 510(k) 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. The listed applicant is Qardio, Inc.. The 510(k) number is K201644.

When did QardioCore receive FDA 510(k) clearance?

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

Who is the listed applicant for QardioCore?

The FDA 510(k) record lists Qardio, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QardioCore?

The FDA product code for QardioCore is DSH.

Other records listing Qardio, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220106QardioArm 2

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.