Irregular Rhythm Notification Feature

Photoplethysmograph Analysis 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 Irregular Rhythm Notification Feature.

Pre-market Notification Details

DeNovo IDDEN180042
Device Name:Irregular Rhythm Notification Feature
ClassificationPhotoplethysmograph Analysis Software For Over-the-counter Use
Applicant Apple Inc Alexandria,  VA  22314
ContactDonna-bea Tillman
Product CodeQDB  
CFR Regulation Number870.2790 [🔎]
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
TypeDirect
Date Received2018-08-09
Decision Date2018-09-11
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00190198909527 DEN180042 000
00190198909510 DEN180042 000

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