DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX
Device Facts
| Record ID | K910771 |
|---|---|
| Device Name | DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX |
| Applicant | New England Medical Instruments, Inc. |
| Product Code | OMB · Neurology |
| Decision Date | Dec 18, 1991 |
| 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.