Hypertension Notification Feature (HTNF)— 510(k) K250507
Substantially EquivalentApple, Inc.
FDA 510(k) clearance K250507 for Hypertension Notification Feature (HTNF), Substantially Equivalent on 2025-09-11. Applicant: Apple, Inc.. Device class: 2.
Clearance details
- Applicant
- Apple, Inc.
- Product code
- Code SFR
- Device class
- Class 2
- Regulation
- 21 CFR 870.2380
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cupertino, CA, US
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