COMBINED PHYSIOLOGICAL MONITORING SYSTEM
Device Facts
| Record ID | K002104 |
|---|---|
| Device Name | COMBINED PHYSIOLOGICAL MONITORING SYSTEM |
| Applicant | Maryrose Cusimano, Ph.D. & Scott Zeff |
| Product Code | IKN · Physical Medicine |
| Decision Date | Oct 10, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.1375 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.
