Atrial Fibrillation History Feature

Photoplethysmograph Analysis Software For Over-the-counter Use

Apple Inc.

The following data is part of a premarket notification filed by Apple Inc. with the FDA for Atrial Fibrillation History Feature.

Pre-market Notification Details

Device IDK213971
510k NumberK213971
Device Name:Atrial Fibrillation History Feature
ClassificationPhotoplethysmograph Analysis Software For Over-the-counter Use
Applicant Apple Inc. 1 Apple Park Way Cupertino,  CA  95014
ContactLuke Olson
CorrespondentLuke Olson
Apple Inc. 1 Apple Park Way Cupertino,  CA  95014
Product CodeQDB  
CFR Regulation Number870.2790 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-20
Decision Date2022-06-03

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