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FDA 510(k)

AliveCor QT Service

K-Number: K212662 · 2022-04-26

ApplicantAliveCor, Inc.
Decision Date2022-04-26
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AliveCor QT Service is the device name listed in this FDA 510(k) record. The listed applicant is AliveCor, Inc.. It received FDA 510(k) clearance on 2022-04-26 under 510(k) 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. The listed applicant is AliveCor, Inc.. The 510(k) number is K212662.

When did AliveCor QT Service receive FDA 510(k) clearance?

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

Who is the listed applicant for AliveCor QT Service?

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

What is the FDA product code for AliveCor QT Service?

The FDA product code for AliveCor QT Service is DQK.

Other records listing AliveCor, Inc. as applicant

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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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