FDA Registration
Active
🇺🇸 United States
Electrocardiograph Software For Over-The-Counter Use - ECG app (2)
Reg #: 3014343954
·
FEI: 3014343954
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- APPLE INC.
- Registration Number
- 3014343954
- FEI Number
- 3014343954
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- One Apple Park Way
- City
- Cupertino
- State
- CA
- ZIP
- 95014
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201525
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 |
|---|---|---|---|---|---|
| Electrocardiograph Software For Over-The-Counter Use | QDA | Class 2 | Cardiovascular | No | 2020-10-08 |
Proprietary Names
Electrocardiograph Software For Over-The-Counter Use - ECG app (2)
Establishment Types
Manufacture Medical Device