Code of Federal Regulations · Section

§ 886.1435 — Maxwell Spot

21 C.F.R. § 886.1435

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(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.

21 C.F.R. § 886.1430 21 C.F.R. § 886.1450

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