FDA Registration
Active
🇺🇸 United States
ECG-AI Low Ejection Fraction 12-Lead algorithm
Reg #: 3029762850
·
FEI: 3029762850
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ANUMANA INC.
- Registration Number
- 3029762850
- FEI Number
- 3029762850
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- One Main Street, Suite 400, East Arcade
- City
- Cambridge
- State
- MA
- ZIP
- 02142
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232699
Owner / Operator
- Firm Name
- Anumana Inc.
- Operator Number
- 10088820
- Address
- One Main Street, Suite 400, East Arcade
- City
- Cambridge
- State
- MA
- Postal Code
- 02142
- Country
- US
- Correspondent
- Suzanne Goodman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reduced Ejection Fraction Machine Learning-Based Notification Software | QYE | Class 2 | Cardiovascular | No | 2023-10-13 |
Proprietary Names
ECG-AI Low Ejection Fraction 12-Lead algorithm
Establishment Types
Manufacture Medical Device