Neuron-Spectrum-AM
Basic Information
- Brand Name
- Neuron-Spectrum-AM
- Primary DI
- 04650075331392
- Version / Model
- Neuron-Spectrum-AM
- Company Name
- NEUROSOFT, OOO
- Labeler DUNS
- 643212926
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-19
- Public Version
- 1
- Public Version Date
- 2022-12-27
- Public Version Status
- New
- Public Device Record Key
- 6691d07b-3757-4c49-925b-07454793b333
Device Description
Indications for Use The Neuron-Spectrum-AM system with Neuron-Spectrum.NET software is intended for use as a digital neurophysiological system for recording, processing, and displaying biopotential signals such as Electroencephalography (EEG) and Polysomnography (PSG) derived from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes. The device is portable and can register up to 21 EEG channels, 4 polygraphic channels, 1 breath channel, and 1 direct current channel. The device does not provide alarms, does not provide automated event marking and does not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in patient care institutions, diagnostics centers, neurosurgical hospitals, experimental laboratories, and sleep laboratories. The device can also be used as a home use device under supervision of qualified personnel. The patient group includes all ages and sexes.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | Neurology | 882.1400 | 2 |
| OLV | Standard Polysomnograph With Electroencephalograph | Neurology | 882.1400 | 2 |
| GWQ | Full-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 | 04650075331392 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220254 | 000 |