FDA Registration
Active
🇺🇸 United States
Compumedics Grael System
Reg #: 1650946
·
FEI: 3002716534
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- COMPUMEDICS USA, INC.
- Registration Number
- 1650946
- FEI Number
- 3002716534
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 5015 West WT Harris Blvd, Suite E
- City
- Charlotte
- State
- NC
- ZIP
- 28269
- Country
- US
Regulatory Submissions
- 510(k) Number
- K093223
Owner / Operator
- Firm Name
- Compumedics USA Inc.
- Operator Number
- 9029712
- Address
- 5015 W W.T. Harris Blvd, Suite E
- City
- Charlotte
- State
- NC
- Postal Code
- 28269
- Country
- US
- Correspondent
- Bailey K Lewis
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2023-12-04 |
| Standard Polysomnograph With Electroencephalograph | OLV | Class 2 | Neurology | No | 2023-12-04 |
| Automatic Event Detection Software For Polysomnograph With Electroencephalograph | OLZ | Class 2 | Neurology | No | 2023-12-04 |
Proprietary Names
Compumedics Grael System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device