{"data":{"id":"us/21-cfr-874.4770","jurisdiction":"us","citation":"21 CFR 874.4770","heading":"Otoscope.","body":"(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.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 874—EAR, NOSE, AND THROAT DEVICES","Subpart E—Surgical Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"60fabe6949b109c61c43f75216ca42f1e51a6d7393a49d746783ad814f4201d6","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-874.4760","next":"us/21-cfr-874.4780"},"notice":"GroundRules: Original legal text. Not legal advice."}