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Title 21 Part 886 → Subpart B → §886.1435

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart B → §886.1435

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart B → §886.1435

e-CFR data is current as of September 12, 2019

Title 21Chapter ISubchapter HPart 886Subpart B → §886.1435


Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart B—Diagnostic Devices


§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]