Code of Federal Regulations · Section

§ 886.1270 — Exophthalmometer

21 C.F.R. § 886.1270

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(a) Identification. An exophthalmometer is a device, such as a ruler, gauge, or caliper, intended to measure the degree of exophthalmos (abnormal protrusion of the eyeball).

(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 § 886.9.

Authorizing Statute