FDA Registration
Active
🇺🇸 United States
CARE 365 CARDIAC PLATFORM
Reg #: 3029987970
·
FEI: 3029987970
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- CARE 365, LLC
- Registration Number
- 3029987970
- FEI Number
- 3029987970
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10 Melaney Dr
- City
- Monsey
- State
- NY
- ZIP
- 10952
- Country
- US
Regulatory Submissions
- 510(k) Number
- K011625
Owner / Operator
- Firm Name
- Care 365, LLC
- Operator Number
- 10089098
- Address
- 10 Melaney Drive
- City
- Monsey
- State
- NY
- Postal Code
- 10952
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2023-11-06 |
Proprietary Names
CARE 365 CARDIAC PLATFORM
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device