EP AMP, MODEL #901
Device Facts
| Record ID | K925346 |
|---|---|
| Device Name | EP AMP, MODEL #901 |
| Applicant | Quinton Electrophysiology Corp. |
| Product Code | DRR · Cardiovascular |
| Decision Date | Apr 30, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2050 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A biopotential amplifier and signal conditioner is a device used to amplify or condition an electrical signal of biologic origin.
