meddevicedb.com FDA Device Reference

Irregular Rhythm Notification Feature

DEN180042 Class II Direct
Decision Date
2018-09-11
Sponsor / Applicant
Apple, Inc.

Technical Specification

510(k) Submission ID DEN180042
Product Code QDB
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.2790
Decision Date 2018-09-11
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Irregular Rhythm Notification Feature received FDA 510(k) clearance under submission number DEN180042, sponsored by Apple, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-09-11.

Classification & Regulation

This clearance is catalogued under FDA product code QDB and 21 CFR 870.2790, within the Cardiovascular review panel as a Class II device.