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Title 21 Part 880 → Subpart C → §880.2200

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart C → §880.2200

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart C → §880.2200

e-CFR data is current as of September 19, 2019

Title 21Chapter ISubchapter HPart 880Subpart C → §880.2200


Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart C—General Hospital and Personal Use Monitoring Devices


§880.2200   Liquid crystal forehead temperature strip.

(a) Identification. A liquid crystal forehead temperature strip is a device applied to the forehead that is used to indicate the presence or absence of fever, or to monitor body temperature changes. The device displays the color changes of heat sensitive liquid crystals corresponding to the variation in the surface temperature of the skin. The liquid crystals, which are cholesteric esters, are sealed in plastic.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59228, Nov. 3, 1998]