{"data":{"id":"us/21-cfr-868.5580","jurisdiction":"us","citation":"21 CFR 868.5580","heading":"Oxygen mask.","body":"(a) Identification. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.\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 § 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":"d41b1fea2c4b8a5b49b976801811f864867a0262e3691e82e1e7e92726110c0f","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-868.5570","next":"us/21-cfr-868.5590"},"notice":"GroundRules: Original legal text. Not legal advice."}