HARMONE-SCHWARZER EEG SYSTEM
Device Facts
| Record ID | K010728 |
|---|---|
| Device Name | HARMONE-SCHWARZER EEG SYSTEM |
| Applicant | Stellate Systems |
| Product Code | OLV · Neurology |
| Decision Date | May 21, 2001 |
| Decision | SESE |
| Submission Type | Abbreviated |
| 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.