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Regulatory filing

K200948 (us_fda)

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

fda 510k · cleared · decided 2020-09-11

Machine-readable surfaces

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Data documentation: /data

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

Covered models (1)

Fitbit (Charge / Sense / Versa)

Sources (1)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200948

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Identity

6189ec99-f7d2-4434-9950-30c5c7cc5765