Regulatory filing
K212372 (us_fda)
510(k) clearance for the Fitbit irregular heart rhythm notification (PPG-based AFib detection); cleared 2022.
fda 510k · cleared · decided 2022-04-08
Machine-readable surfaces
- Markdown mirror: /regulatory-filings/fda-k212372-fitbit-afib.md
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- REST API: /v1/filings/f5cc282c-68ae-4302-ae99-a7348106157b
- Revision history: /regulatory-filings/fda-k212372-fitbit-afib/history
- Data documentation: /data
Key facts
- Jurisdiction
- us_fda
- Filing type
- fda 510k
- Status
- cleared
- Filing number
- K212372
- Filing date
- 2021-07-30
- Decision date
- 2022-04-08
- Verification posture
- verified
Applicant
Covered models (1)
Sources (1)
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Identity
f5cc282c-68ae-4302-ae99-a7348106157b