# K221774 (us_fda)

FDA 510(k) K221774 for Garmin ECG App (Jan 2023). 99.5% sensitivity, 100% specificity.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_510k
- Status: cleared
- Filing number: K221774
- Filing date: 2023-01-12
- Decision date: 2023-01-12
- Verification posture: verified

## Applicant

- [Garmin](/companies/garmin.md)

## Covered models (1)

- [Garmin (Venu / Fenix / Forerunner)](/models/garmin-watch.md)

## Sources (1)

- [https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221774.pdf](https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221774.pdf)

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