Regulatory filing

K212372 (us_fda)

FDA 510(k) K212372 for Fitbit Irregular Rhythm Notifications / AFib detection (Apr 2022).

fda 510k · cleared · decided 2022-04-08

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Key facts

Jurisdiction: us_fda
Filing type: fda 510k
Status: cleared
Filing number: K212372
Filing date: 2022-04-08
Decision date: 2022-04-08
Verification posture: verified

Applicant

Covered models (1)

Fitbit (Charge / Sense / Versa)

Sources (1)

https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212372.pdf

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Identity

86450852-2334-46f9-91f5-eaf2a0f66e53