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FDA 510(k)

AliveCor QT Service

K-Number: K212662 · 2022-04-26

Decision Date2022-04-26
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AliveCor QT Service is a medical device manufactured by AliveCor, Inc.. It received FDA 510(k) clearance on 2022-04-26 under approval number K212662. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AliveCor QT Service?

AliveCor QT Service is a medical device that received FDA 510(k) clearance on 2022-04-26. It is manufactured by AliveCor, Inc.. The 510(k) number is K212662.

When was AliveCor QT Service approved by the FDA?

AliveCor QT Service received FDA 510(k) clearance on 2022-04-26, under approval number K212662.

What company makes AliveCor QT Service?

AliveCor QT Service is manufactured by AliveCor, Inc..

What is the FDA product code for AliveCor QT Service?

The FDA product code for AliveCor QT Service is DQK.

Other Devices by AliveCor, Inc.

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Related Devices (Code: DQK)

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.