FDA Registration
Active
🇺🇸 United States
CardioFlux with Faraday Analytical Cloud (FAC)
Reg #: 3014574535
·
FEI: 3014574535
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GENETESIS, INC.
- Registration Number
- 3014574535
- FEI Number
- 3014574535
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5412 Courseview Drive, Suite 150
- City
- Mason
- State
- OH
- ZIP
- 45040
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182571
Owner / Operator
- Firm Name
- Genetesis, Inc.
- Operator Number
- 10060081
- Address
- 5412 Courseview Drive, Suite 150
- City
- Mason
- State
- OH
- Postal Code
- 45040
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2019-03-27 |
Proprietary Names
CardioFlux with Faraday Analytical Cloud (FAC)
Establishment Types
Manufacture Medical Device