WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)
Device Facts
| Record ID | K001103 |
|---|---|
| Device Name | WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED) |
| Applicant | Excel Tech. , Ltd. |
| Product Code | GWQ · Neurology |
| Decision Date | Jun 30, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.