{"data":{"id":"us/21-cfr-868.5620","jurisdiction":"us","citation":"21 CFR 868.5620","heading":"Breathing mouthpiece.","body":"(a) Identification. A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.\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":"1b71dc2b7840c9fdb5e51e75ed94ee768c4fc65a97ebb396767e09b7655c364d","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-868.5600","next":"us/21-cfr-868.5630"},"notice":"GroundRules: Original legal text. Not legal advice."}