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510(k) K212516

IRNF App by Apple, Inc. — Product Code QDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2021
Date Received
August 10, 2021
Clearance Type
Traditional
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)
  • K201525 — ECG App (October 8, 2020)
  • DEN180042 — Irregular Rhythm Notification Feature (September 11, 2018)
  • 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)
  • DEN180042 — Irregular Rhythm Notification Feature (September 11, 2018)