FDA Registration
Active
🇺🇸 United States
Eko Analysis Software
Reg #: 3011651230
·
FEI: 3011651230
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Eko Health, Inc.
- Registration Number
- 3011651230
- FEI Number
- 3011651230
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2100 Powell St, Suite 300
- City
- Emeryville
- State
- CA
- ZIP
- 94608
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192004
Owner / Operator
- Firm Name
- Eko Health, Inc.
- Operator Number
- 10049275
- Address
- 2100 Powell St, Suite 300
- City
- Emeryville
- State
- CA
- Postal Code
- 94608
- Country
- US
- Correspondent
- Connor Landgraf
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stethoscope, Electronic | DQD | Class 2 | Cardiovascular | No | 2020-09-14 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2020-09-14 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2020-09-14 |
Proprietary Names
Eko Analysis Software
SENSORA
Establishment Types
Manufacture Medical Device