BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT
Device Facts
| Record ID | K853652 |
|---|---|
| Device Name | BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT |
| Applicant | Fisher Imaging Corp. |
| Product Code | DRR · Cardiovascular |
| Decision Date | Jan 16, 1986 |
| 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.