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Regulatory filing

K230292 (us_fda)

510(k) clearance for the Samsung Galaxy Watch irregular heart rhythm notification; cleared 2023.

fda 510k · cleared · decided 2023-05-02


Machine-readable surfaces

Key facts

Jurisdiction
us_fda
Filing type
fda 510k
Status
cleared
Filing number
K230292
Filing date
2023-02-02
Decision date
2023-05-02
Verification posture
verified

Applicant

Samsung Electronics

Covered models (1)

Sources (1)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230292

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Identity

d705d6a3-96cb-4db9-9251-f18167158df8