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Regulatory filing

K250507 (us_fda)

510(k) clearance for the Apple Watch hypertension (chronic high blood pressure) notification feature; cleared 2025.

fda 510k · cleared · decided 2025-09-11


Machine-readable surfaces

Key facts

Jurisdiction
us_fda
Filing type
fda 510k
Status
cleared
Filing number
K250507
Filing date
2025-02-21
Decision date
2025-09-11
Verification posture
verified

Applicant

Apple

Covered models (1)

Sources (1)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250507

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Identity

c98c04d2-925c-4bfa-81f9-7c009fe4d9a9