meddevicedb.com FDA Device Reference

ECG App

DEN180044 Class II Direct
Decision Date
2018-09-11
Sponsor / Applicant
Apple, Inc.

Technical Specification

510(k) Submission ID DEN180044
Product Code QDA
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.2345
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

ECG App received FDA 510(k) clearance under submission number DEN180044, 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 QDA and 21 CFR 870.2345, within the Cardiovascular review panel as a Class II device.