Regulatory filing

K201456 (us_fda)

FDA 510(k) K201456 for Withings ScanWatch ECG and SpO2 (Oct 2021).

fda 510k · cleared · decided 2021-10-05

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Key facts

Jurisdiction: us_fda
Filing type: fda 510k
Status: cleared
Filing number: K201456
Filing date: 2021-10-05
Decision date: 2021-10-05
Verification posture: verified

Applicant

Covered models (1)

Withings ScanWatch

Sources (1)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201456

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Identity

7d1c7968-12f4-4530-9add-9f1d6090da74