Cleared Traditional

IRNF App

K212516 · Apple, Inc. · Cardiovascular
Oct 2021
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K212516 is an FDA 510(k) clearance for the IRNF App, a Photoplethysmograph Analysis Software For Over-the-counter Use (Class II — Special Controls, product code QDB), submitted by Apple, Inc. (Cupertino, US). The FDA issued a Cleared decision on October 22, 2021, 73 days after receiving the submission on August 10, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2790.

Submission Details

510(k) Number K212516 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 2021
Decision Date October 22, 2021
Days to Decision 73 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QDB — Photoplethysmograph Analysis Software For Over-the-counter Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2790
Definition 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.