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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 886 - Ophthalmic Devices |
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Subpart B - Diagnostic Devices |
§ 886.1270 - Exophthalmometer.
Latest version.
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§ 886.1270 Exophthalmometer.
(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.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38810, July 25, 2001]