Hypertension Notification Feature (HTNF)
FDA 510(k) clearance K250507 · decided 2025-09-11
Clearance details
- K-number
- K250507
- Device name
- Hypertension Notification Feature (HTNF)
- Applicant
- Apple, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-02-21
- Decision date
- 2025-09-11
- Days to decision
- 202 days
- Clearance type
- Traditional
- Product code
- SFR
- Device class
- 2
- Regulation number
- 870.2380
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Cupertino, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.