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FDA 510(k)

Fitbit ECG App

K-Number: K200948 · 2020-09-11

ApplicantFitbit, Inc.
Decision Date2020-09-11
Product CodeQDA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fitbit ECG App is a medical device manufactured by Fitbit, Inc.. It received FDA 510(k) clearance on 2020-09-11 under approval number K200948. 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 Fitbit ECG App?

Fitbit ECG App is a medical device that received FDA 510(k) clearance on 2020-09-11. It is manufactured by Fitbit, Inc.. The 510(k) number is K200948.

When was Fitbit ECG App approved by the FDA?

Fitbit ECG App received FDA 510(k) clearance on 2020-09-11, under approval number K200948.

What company makes Fitbit ECG App?

Fitbit ECG App is manufactured by Fitbit, Inc..

What is the FDA product code for Fitbit ECG App?

The FDA product code for Fitbit ECG App is QDA.

Other Devices by Fitbit, Inc.

K212372Fitbit Irregular Rhythm Notifications

Related Devices (Code: 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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