Irregular Rhythm Notification Feature (IRNF)— 510(k) K231173

Substantially Equivalent

Apple, Inc.

FDA 510(k) clearance K231173 for Irregular Rhythm Notification Feature (IRNF), Substantially Equivalent on 2023-07-21. Applicant: Apple, Inc.. Device class: 2.

Clearance details

Applicant
Apple, Inc.
Product code
Code QDB
Device class
Class 2
Regulation
21 CFR 870.2790
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cupertino, CA, US
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