Devices · Apple Inc.

IRNF App

Apple Inc. is listed for IRNF App (K212516). The FDA list gives October 22, 2021 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QDB as “Photoplethysmograph Analysis Software For Over-The-Counter Use”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212516

Official FDA database record

Date of final decision

October 22, 2021

Company on the FDA list

Apple Inc.

Lead panel

Cardiovascular

Primary product code

QDB

openFDA device name for the code

Photoplethysmograph Analysis Software For Over-The-Counter Use

Device class

2

Regulation number

870.2790

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary