FDA Registration
Active
🇺🇸 United States
Biovitals Analytics Engine
Reg #: 3018490434
·
FEI: 3018490434
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Biofourmis Inc.
- Registration Number
- 3018490434
- FEI Number
- 3018490434
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 40 Burton Hills Blvd Ste 200
- City
- Nashville
- State
- TN
- ZIP
- 37215
- Country
- US
Regulatory Submissions
- 510(k) Number
- K183282
Owner / Operator
- Firm Name
- Biofourmis Inc.
- Operator Number
- 10081347
- Address
- 40 Burton Hills Blvd, Suite 200
- City
- Nashville
- State
- TN
- Postal Code
- 37215
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multivariate Vital Signs Index | PLB | Class 2 | Cardiovascular | No | 2025-05-28 |
Proprietary Names
Biovitals Analytics Engine
Establishment Types
Complaint File Establishment per 21 CFR 820.198