HORIZON 9000/HIS OPTION AMPLIFIER
Device Facts
| Record ID | K914381 |
|---|---|
| Device Name | HORIZON 9000/HIS OPTION AMPLIFIER |
| Applicant | Mennen Medical, Inc. |
| Product Code | DRR · Cardiovascular |
| Decision Date | Jan 28, 1992 |
| 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.