21 CFR 870.2620 — Monitor, Line Isolation
Cardiovascular (CV) · Part 870 Subpart C—Cardiovascular Monitoring Devices · § 870.2620
Identification
A line isolation monitor is a device used to monitor the electrical leakage current from a power supply electrically isolated from the commercial power supply received from a utility company.
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DRI | Monitor, Line Isolation | 1 | 4 |
