§ 886.1435. Maxwell spot.
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/us/cfr/t21/s§ 886.1435·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]