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Electronic Code of Federal Regulations

e-CFR data is current as of February 26, 2020

Title 21Chapter ISubchapter HPart 870Subpart C → §870.2600


Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart C—Cardiovascular Monitoring Devices


§870.2600   Signal isolation system.

(a) 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.

(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, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001]

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