ADR-2000 AMBULATORY DATA RECORDING SYSTEM
Device Facts
| Record ID | K880977 |
|---|---|
| Device Name | ADR-2000 AMBULATORY DATA RECORDING SYSTEM |
| Applicant | Aaron Laboratories, Inc. |
| Product Code | IKN · Physical Medicine |
| Decision Date | Apr 13, 1988 |
| 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.
