FDA Registration
Active
🇨🇦 Canada
Cerebra Sleep System
Reg #: 3008517706
·
FEI: 3008517706
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- CEREBRA MEDICAL
- Registration Number
- 3008517706
- FEI Number
- 3008517706
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1470 Willson Place Unit B
- City
- Winnipeg Manitoba
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K213007
Owner / Operator
- Firm Name
- Cerebra Medical
- Operator Number
- 10033319
- Address
- 1470 Willson Place Unit B
- City
- Winnipeg
- State
- Manitoba
- Postal Code
- R3T 3N9
- Country
- CA
US Agent
- Business Name
- MDSS USA LLC
- Contact Name
- Marissa Vilchez
- Address
- 6118 W. Lawrence Avenue
- City
- Chicago
- State
- IL
- ZIP
- 60630
- Country
- US
- [email protected]
- Phone
- 312 9751694
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Standard Polysomnograph With Electroencephalograph | OLV | Class 2 | Neurology | No | 2022-07-07 |
| Reduced- Montage Standard Electroencephalograph | OMC | Class 2 | Neurology | No | 2022-07-07 |
| Automatic Event Detection Software For Polysomnograph With Electroencephalograph | OLZ | Class 2 | Neurology | No | 2022-07-07 |
Proprietary Names
Cerebra Sleep System
Establishment Types
Manufacture Medical Device