Regulatory filing

K200948 (us_fda)

FDA 510(k) K200948 for Fitbit ECG App (Sep 2020).

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

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Key facts

Jurisdiction: us_fda
Filing type: fda 510k
Status: cleared
Filing number: K200948
Filing date: 2020-09-11
Decision date: 2020-09-11
Verification posture: verified

Applicant

Covered models (1)

Fitbit (Charge / Sense / Versa)

Sources (1)

https://www.accessdata.fda.gov/cdrh_docs/pdf20/K200948.pdf

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Identity

6a38c863-03a7-4251-a30d-4360ef39caf3