FDA Registration
Active
🇺🇸 United States
Cervello
Reg #: 3007323246
·
FEI: 3007323246
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Blackrock Microsystems
- Registration Number
- 3007323246
- FEI Number
- 3007323246
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 630 S Komas Dr Ste 200
- City
- Salt Lake City
- State
- UT
- ZIP
- 84108
- Country
- US
Regulatory Submissions
- 510(k) Number
- K122196
Owner / Operator
- Firm Name
- Blackrock Microsystems
- Operator Number
- 10027942
- Address
- 630 Komas Drive, Suite 200
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84108
- Country
- US
- Correspondent
- Matthew Trebella
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Standard Polysomnograph With Electroencephalograph | OLV | Class 2 | Neurology | No | 2017-06-26 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2017-06-26 |
| Conditioner, Signal, Physiological | GWK | Class 2 | Neurology | No | 2017-06-26 |
| Amplifier, Physiological Signal | GWL | Class 2 | Neurology | No | 2017-06-26 |
Proprietary Names
Cervello
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility