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 IDDEN180044
Device Name:ECG App
ClassificationElectrocardiograph Software For Over-the-counter Use
Applicant Apple Inc c/o Biologics Consulting Group 400 N Washington St., Suite 100 Alexandria,  VA  22314
ContactDonna-bea Tillman
Product CodeQDA  
CFR Regulation Number870.2345 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice 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 BoardCardiovascular
Classification AdvisoryCardiovascular
Date Received2018-08-14
Decision Date2018-09-11
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order


Device IdentifiersubmissionNumberSupplement
00190198909541 DEN180044 000
00190198909534 DEN180044 000

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