FDA Registration
Active
🇺🇸 United States
KardiaCore
Reg #: 3009715978
·
FEI: 3009715978
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- AliveCor
- Registration Number
- 3009715978
- FEI Number
- 3009715978
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 189 N Bernardo Avenue, Suite 100
- City
- Mountain View
- State
- CA
- ZIP
- 94043
- Country
- US
Regulatory Submissions
- 510(k) Number
- K220350
Owner / Operator
- Firm Name
- AliveCor, Inc.
- Operator Number
- 10041430
- Address
- 189 N Bernardo Avenue, Suite 100
- City
- Mountain View
- State
- CA
- Postal Code
- 94043
- Country
- US
- Correspondent
- Samip Shah
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrocardiograph Software For Over-The-Counter Use | QDA | Class 2 | Cardiovascular | No | 2022-06-24 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2022-06-24 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2022-06-24 |
Proprietary Names
KardiaCore
KardiaCore Application
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device