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FDA 510(k)

Garmin ECG App

K-Number: K221774 · 2023-01-12

ApplicantGarmin International, Inc.
Decision Date2023-01-12
Product CodeQDA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Garmin ECG App is a medical device manufactured by Garmin International, Inc.. It received FDA 510(k) clearance on 2023-01-12 under approval number K221774. The device is classified under product code QDA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Garmin ECG App?

Garmin ECG App is a medical device that received FDA 510(k) clearance on 2023-01-12. It is manufactured by Garmin International, Inc.. The 510(k) number is K221774.

When was Garmin ECG App approved by the FDA?

Garmin ECG App received FDA 510(k) clearance on 2023-01-12, under approval number K221774.

What company makes Garmin ECG App?

Garmin ECG App is manufactured by Garmin International, Inc..

What is the FDA product code for Garmin ECG App?

The FDA product code for Garmin ECG App is QDA.

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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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