21 CFR 880.6970 — Device, Vein Location, Liquid Crystal

General Hospital (HO) · Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices · § 880.6970

Identification

A liquid crystal vein locator is a device used to indicate the location of a vein by revealing variations in the surface temperature of the skin by displaying the color changes of heat sensitive liquid crystals (cholesteric esters).

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 § 880.9.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KZADevice, Vein Location, Liquid Crystal16
Innolitics

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