DRJ · System, Signal Isolation
Cardiovascular · 21 CFR 870.2600 · Class 1
Overview
| Product Code | DRJ |
|---|---|
| Device Name | System, Signal Isolation |
| Regulation | 21 CFR 870.2600 |
| Device Class | Class 1 |
| Review Panel | Cardiovascular |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K832828 | CENTURION CARDIAC DETECTOR | Clinical Data Instruments, Inc. | May 9, 1984 | SESE |
| K822590 | PRESSURE ISOLATION AMPLIFIER #9813 517 | Honeywell, Inc. | Oct 4, 1982 | SESE |
| K771685 | AMPLIFIER MODEL N5A-HIS | Honeywell, Inc. | Sep 14, 1977 | SESE |
| K771684 | AMPLIFIER MODEL N5A-ECG | Honeywell, Inc. | Sep 14, 1977 | SESE |
Top Applicants
- Honeywell, Inc. — 3 clearances
- Clinical Data Instruments, Inc. — 1 clearance
