# K200948 (us_fda)

510(k) clearance for the Fitbit ECG app (single-lead electrocardiogram) for AFib assessment; cleared 2020.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_510k
- Status: cleared
- Filing number: K200948
- Filing date: 2020-04-08
- Decision date: 2020-09-11
- Verification posture: verified

## Applicant

- [Fitbit](/companies/fitbit.md)

## Covered models (1)

- [Fitbit (Charge / Sense / Versa)](/models/fitbit-tracker.md)

## Sources (1)

- [https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200948](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200948)

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