AMPLIFIER MODEL N5A-HIS
Device Facts
| Record ID | K771685 |
|---|---|
| Device Name | AMPLIFIER MODEL N5A-HIS |
| Applicant | Honeywell, Inc. |
| Product Code | DRJ · Cardiovascular |
| Decision Date | Sep 14, 1977 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2600 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A signal isolation system is a device that electrically isolates the patient from equipment connected to the commercial power supply received from a utility company. This isolation may be accomplished, for example, by transformer coupling, acoustic coupling, or optical coupling.
