APPLE INC.

FDA Device Registration & Listing · Cupertino, CA, US · Registration 3014343954

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014343954
FEI Number
3014343954
Entity Name
APPLE INC.
City/State/Country
Cupertino, CA, US
Establishment Address
One Apple Park Way, Cupertino, CA 95014, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Apple Inc. (Owner Number: 10058630)
Owner / Operator Contact Address
One Apple Park Way, Cupertino, CA 95014, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K213971
PMA Number
N/A

All Registered Proprietary Names

Irregular Rhythm Notification Feature Cycle Tracking Photoplethysmograph Analysis Software For Over-The-Counter Use - Irregular Rhythm Notification Feature (2) ECG App Medical Imaging Calibration Feature (MICF) Hypertension Notification Feature (HTNF) Hearing Aid Feature Hearing Test Feature (HTF) Sleep Apnea Notification Feature Atrial Fibrillation History Feature

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QDB Photoplethysmograph Analysis Software For Over-The-Counter Use Cardiovascular Class 2 870.2790 2018-10-17
LHD Device, Fertility Diagnostic, Proceptive Unknown Class U N/A 2022-04-07
QDB Photoplethysmograph Analysis Software For Over-The-Counter Use Cardiovascular Class 2 870.2790 2021-12-10
QDA Electrocardiograph Software For Over-The-Counter Use Cardiovascular Class 2 870.2345 2018-10-17
SHN Calibration Software For Radiology Displays Radiology Class 1 892.1940 2026-04-14
SFR Hypertension Machine Learning-Based Notification Software Cardiovascular Class 2 870.2380 2025-09-16
SCR Air-Conduction Hearing Aid Software Ear, Nose, Throat Class 2 874.3335 2024-09-13
EWO Audiometer Ear, Nose, Throat Class 2 874.1050 2024-10-11
QZW Over-The-Counter Device To Assess Risk Of Sleep Apnea Anesthesiology Class 2 868.2378 2024-09-16
QDB Photoplethysmograph Analysis Software For Over-The-Counter Use Cardiovascular Class 2 870.2790 2022-06-06

Official Correspondent

Sam Surette

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Apple Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243236 Whoop., Inc. WHOOP ECG (electrocardiogram) Feature (1.0) 2025-04-04
K780270 Maico Hearing Instruments, Inc. COMPUTER AUDIOMETER - MA26 1978-02-27
K923074 Life-Tech Intl., Inc. DANPLEX SCREENING AUDIOMETER 1992-09-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014343954. Last updated year: 2026. Please use registration number 3014343954 when referencing this establishment in official correspondence.
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