FDA UDI
In Commercial Distribution
🇺🇸 United States
COGNISION EEG/EP System
DI: B706H10000
·
Model: 3000
·
Neuronetrix Solutions, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- COGNISION EEG/EP System
- Primary DI
- B706H10000
- Version / Model
- 3000
- Catalog Number
- H1000
- Company Name
- Neuronetrix Solutions, LLC
- Labeler DUNS
- 117102035
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-12
- Public Version
- 1
- Public Version Date
- 2025-03-20
- Public Version Status
- New
- Public Device Record Key
- cc1f5dea-ca15-433d-8396-6b497755c983
Device Description
COGNISION EEG/EP System. Includes headset, headset control unit, earphones, cables, and system case.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OMC | Reduced- Montage Standard Electroencephalograph | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11467 | Electroencephalograph | An electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B706H10000 | HIBCC |
Customer Contacts
- Phone
- 502-561-9040
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141316 | 000 |