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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 |
§ 886.1435 - Maxwell spot.
Latest version.
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§ 886.1435 Maxwell spot.
(a) Identification. A Maxwell spot is an AC-powered device that is a light source with a red and blue filter intended to test macular function.
(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.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38811, July 25, 2001]