Regulatory filing

K221774 (us_fda)

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

fda 510k · cleared · decided 2023-01-12

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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

Covered models (1)

Garmin (Venu / Fenix / Forerunner)

Sources (1)

https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221774.pdf

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Identity

4792de9c-7b90-4c00-8265-3af5956f2e00