FDA Registration
Active
🇺🇸 United States
COMPUMEDICS USA, INC.
Reg #: 1650946
·
FEI: 3002716534
·
Expires 2026
Products
12
Proprietary Names
20
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- COMPUMEDICS USA, INC.
- Registration Number
- 1650946
- FEI Number
- 3002716534
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 5015 West WT Harris Blvd, Suite E
- City
- Charlotte
- State
- NC
- ZIP
- 28269
- Country
- US
Regulatory Submissions
- 510(k) Number
- K011241
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 |
|---|---|---|---|---|---|
| Source Localization Software For Electroencephalograph Or Magnetoencephalograph | OLX | Class 2 | Neurology | No | 2008-01-24 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2010-12-16 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2010-12-16 |
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2010-12-16 |
| Stimulator, Photic, Evoked Response | GWE | Class 2 | Neurology | No | 2010-12-16 |
| Media, Electroconductive | GYB | Class 2 | Neurology | No | 2008-01-24 |
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | 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 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2008-01-24 |
| Reduced- Montage Standard Electroencephalograph | OMC | Class 2 | Neurology | No | 2025-12-09 |
| Magnetoencephalograph | OLY | Class 2 | Neurology | No | 2023-12-04 |
Proprietary Names
SOURCE software
NEUVO
QUIK-GEL
Compumedics Somte System
Compumedics Grael System
QUIK-CAP
Falcon HST
SYNAMPS 2/RT
Okti 32 Ch Ambulatory EEG Recorder Only
Okti 64 Ch Ambulatory EEG System
Okti 128 Ch Ambulatory EEG Recorder Only
Okti Ethernet Connection Kit
Okti 64 Ch Ambulatory EEG Recorder Only
Okti 32 Ch Ambulatory EEG System
Okti 128 Ch Ambulatory EEG System
Somfit D
CURRY software
Orion LifeSpan MEG
Compumedics Siesta System
Compumedics Somte PSG System
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198