DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM
Device Facts
| Record ID | K944833 |
|---|---|
| Device Name | DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM |
| Applicant | New England Medical Monitoring Co. |
| Product Code | OMB · Neurology |
| Decision Date | May 4, 1995 |
| 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.
