FDA Registration
Active
🇺🇸 United States
APPLE INC.
Reg #: 3014343954
·
FEI: 3014343954
·
Expires 2026
Products
11
Proprietary Names
14
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- APPLE INC.
- Registration Number
- 3014343954
- FEI Number
- 3014343954
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- One Apple Park Way
- City
- Cupertino
- State
- CA
- ZIP
- 95014
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN180042
Owner / Operator
- Firm Name
- Apple Inc.
- Operator Number
- 10058630
- Address
- One Apple Park Way
- City
- Cupertino
- State
- CA
- Postal Code
- 95014
- Country
- US
- Correspondent
- Sam Surette
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Photoplethysmograph Analysis Software For Over-The-Counter Use | QDB | Class 2 | Cardiovascular | No | 2018-10-17 |
| Device, Fertility Diagnostic, Proceptive | LHD | Class U | Unknown | No | 2022-04-07 |
| Electrocardiograph Software For Over-The-Counter Use | QDA | Class 2 | Cardiovascular | No | 2018-10-17 |
| Calibration Software For Radiology Displays | SHN | Class 1 | Radiology | No | 2026-04-14 |
| Hypertension Machine Learning-Based Notification Software | SFR | Class 2 | Cardiovascular | No | 2025-09-16 |
| Air-Conduction Hearing Aid Software | SCR | Class 2 | Ear, Nose, Throat | No | 2024-09-13 |
| Audiometer | EWO | Class 2 | Ear, Nose, Throat | No | 2024-10-11 |
| Over-The-Counter Device To Assess Risk Of Sleep Apnea | QZW | Class 2 | Anesthesiology | No | 2024-09-16 |
| Lens, Spectacle, Non-Custom (Prescription) | HQG | Class 1 | Ophthalmic | No | 2023-06-16 |
| Spectacle, Magnifying | HOI | Class 1 | Ophthalmic | No | 2024-01-08 |
| Digital Prismatic Correction | SCW | Class 1 | Ophthalmic | No | 2025-09-09 |
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
Electrocardiograph Software For Over-The-Counter Use - ECG app (2)
Optical Insert
ZEISS Optical Insert- Reader
Digital Prism Correction Feature (DPCF)
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility