Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 870 - CARDIOVASCULAR DEVICES
/ Subpart C - Cardiovascular Monitoring Devices / § 870.2620 Line isolation monitor.
§ 870.2620 Line isolation monitor.
(a) 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.
(b) Classification. 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.