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510(k) DEN180042

Irregular Rhythm Notification Feature by Apple, Inc. — Product Code QDB

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
September 11, 2018
Date Received
August 9, 2018
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photoplethysmograph Analysis Software For Over-The-Counter Use
Device Class
Class II
Regulation Number
870.2790
Review Panel
CV
Submission Type

A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.

Other clearances by Apple, Inc.

  • K250507 — Hypertension Notification Feature (HTNF) (September 11, 2025)
  • K250143 — Digital Prism Correction Feature (DPCF) (June 23, 2025)
  • K242058 — Digital Prism Correction Feature (DPCF) (October 21, 2024)
  • K240929 — Sleep Apnea Notification Feature (SANF) (September 13, 2024)
  • DEN230081 — Hearing Aid Feature (HAF) (September 12, 2024)
  • K231173 — Irregular Rhythm Notification Feature (IRNF) (July 21, 2023)
  • K213971 — Atrial Fibrillation History Feature (June 3, 2022)
  • K212516 — IRNF App (October 22, 2021)
  • K201525 — ECG App (October 8, 2020)
  • DEN180044 — ECG App (September 11, 2018)

Other clearances for product code QDB

  • K231173 — Irregular Rhythm Notification Feature (IRNF) (July 21, 2023)
  • K213971 — Atrial Fibrillation History Feature (June 3, 2022)
  • K212372 — Fitbit Irregular Rhythm Notifications (April 8, 2022)
  • K212516 — IRNF App (October 22, 2021)