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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR870.2620]
See Related Information on Line isolation monitor. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 870 -- CARDIOVASCULAR DEVICES

Subpart C--Cardiovascular Monitoring Devices

Sec. 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.

[45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001]

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