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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 the device name listed in this FDA 510(k) record. The listed applicant is Fitbit, Inc.. It received FDA 510(k) clearance on 2020-09-11 under 510(k) 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. The listed applicant is Fitbit, Inc.. The 510(k) number is K200948.

When did Fitbit ECG App receive FDA 510(k) clearance?

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

Who is the listed applicant for Fitbit ECG App?

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

What is the FDA product code for Fitbit ECG App?

The FDA product code for Fitbit ECG App is QDA.

Related Clinical Trials

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.

NCT06865755Collaborative Research: Multiscale Modeling and Intervention for Improving Long-Term MedicationNOT_YET_RECRUITINGNCT07685080"Effectiveness of Supervised and Unsupervised mHealth-based Exercise Interventions on Clinical Outcomes in Adults With Type 2 Diabetes and Obesity Within a Primary Care Context"NOT_YET_RECRUITING

Other records listing Fitbit, 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.

K242967Loss of Pulse DetectionK243778Body Temperature Software (BTS)K212372Fitbit Irregular Rhythm Notifications

Related Devices (Code: QDA)

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.

K240795Withings ECG AppWithingsK243236WHOOP ECG (electrocardiogram) Feature (1.0)Whoop., Inc.K240909Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd.K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd.K221774Garmin ECG AppGarmin International, Inc.K201525ECG AppApple, Inc.

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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