FDA Registration
Active
🇺🇸 United States
Carecube Negative Pressure Isolation Chamber
Reg #: 3010844918
·
FEI: 3010844918
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MENDTRONIX, INC.
- Registration Number
- 3010844918
- FEI Number
- 3010844918
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1855 Dornoch Court, Suite 100
- City
- San Diego
- State
- CA
- ZIP
- 92154
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231256
Owner / Operator
- Firm Name
- Mendtronix Inc.
- Operator Number
- 10053335
- Address
- 1855 Dornoch Court, Suite 100
- City
- San Diego
- State
- CA
- Postal Code
- 92154
- Country
- US
- Correspondent
- Michael Ritter
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Chamber, Patient Isolation | LGM | Class 2 | General Hospital | No | 2025-04-30 |
Proprietary Names
Carecube Negative Pressure Isolation Chamber
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)