FDA.reportPublic FDA data

510(k) K231173

Device
Irregular Rhythm Notification Feature (IRNF)
Applicant
Apple, Inc.
510(k) number
K231173
Product code
QDB
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-21
Date received
2023-04-25
Regulation
870.2790
Classification name
Photoplethysmograph Analysis Software For Over-The-Counter Use
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Bonnie Wu
Address
One Apple Park Way Cupertino CA US 95014 95014

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QDB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K213971Atrial Fibrillation History FeatureApple, Inc.2022-06-03
K212372Fitbit Irregular Rhythm NotificationsFitbit, Inc.2022-04-08
K212516IRNF AppApple, Inc.2021-10-22
DEN180042Irregular Rhythm Notification FeatureApple, Inc.2018-09-11