EEG HOLTER SYSTEMS
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Basic Information
- Primary DI
- +B746EK9011S
- Basic UDI-DI Code
- B-+B746EK9011S
- Reference
- N/A
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- NEUROWAVE SYSTEMS, INC.
Additional Description
The NeuroSENSE Monitoring System is intended to be used to acquire and display bilateral electroencephalographic (EEG) signals to monitor brain function in the OR, ICU, ER, clinical settings and for clinical research. The NeuroSENSE Monitor is to be used under the direction and interpretation of a licensed medical professional. The WAVcns index, a processed EEG variable calculated by the NeuroSENSE Monitor, may be used as aid in monitoring the effects of certain anesthetic agents on adult patients.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12101001 | EEG HOLTER SYSTEMS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | CE 545606 | BSI Group The Netherlands B.V. | Expired |
Available In Countries
Similar Devices
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