ECG App

Electrocardiograph Software For Over-the-counter Use

Apple Inc

The following data is part of a De Novo classification by Apple Inc with the FDA for Ecg App.

Pre-market Notification Details

• DeNovo ID: DEN180044
• Device Name: ECG App
• Classification: Electrocardiograph Software For Over-the-counter Use
• Applicant: Apple Inc c/o Biologics Consulting Group 400 N Washington St., Suite 100 Alexandria, VA 22314
• Contact: Donna-bea Tillman
• Product Code: QDA
• CFR Regulation Number: 870.2345 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
• Review Advisory Board: Cardiovascular
• Classification Advisory: Cardiovascular
• Type: Direct
• Date Received: 2018-08-14
• Decision Date: 2018-09-11
• FDA Review: Decision Summary
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00190198909541	DEN180044	000
00190198909534	DEN180044	000