Regulatory filing
K201456 (us_fda)
510(k) clearance for the Withings ScanWatch ECG and SpO2 functions; cleared 2021.
fda 510k · cleared · decided 2021-10-05
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- Markdown mirror: /regulatory-filings/fda-k201456-withings-scanwatch-ecg.md
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- Revision history: /regulatory-filings/fda-k201456-withings-scanwatch-ecg/history
- Data documentation: /data
Key facts
- Jurisdiction
- us_fda
- Filing type
- fda 510k
- Status
- cleared
- Filing number
- K201456
- Filing date
- 2020-06-01
- Decision date
- 2021-10-05
- Verification posture
- verified
Applicant
Covered models (1)
Sources (1)
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Identity
18746d05-3603-428e-88d2-5eb4baec8f42