{"data":{"id":"us/21-cfr-868.5640","jurisdiction":"us","citation":"21 CFR 868.5640","heading":"Medicinal nonventilatory nebulizer (atomizer).","body":"(a) Identification. A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.\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 § 868.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 868—ANESTHESIOLOGY DEVICES","Subpart F—Therapeutic 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":"f1d0e12e7d5d797229aacf25f14a728b6cc07552df03d7b735489bb06be29adb","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-868.5630","next":"us/21-cfr-868.5650"},"notice":"GroundRules: Original legal text. Not legal advice."}