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Code of Federal Regulations Title 21. Food and Drugs § 21.874.4770 Otoscope

Current as of January 02, 2025 | Updated by Findlaw Staff

(a) Identification. An otoscope is a device intended to allow inspection of the external ear canal and tympanic membrane under magnification. The device provides illumination of the ear canal for observation by using an AC- or battery-powered light source and an optical magnifying system.

(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 § 874.9 only when used in the external ear canal.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.874.4770 Otoscope - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-874-4770/

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