{"data":{"id":"us/21-cfr-868.5600","jurisdiction":"us","citation":"21 CFR 868.5600","heading":"Venturi mask.","body":"(a) Identification. A venturi mask is a device containing an air-oxygen mixing mechanism that dilutes 100 percent oxygen to a predetermined concentration and delivers the mixed gases to a patient.\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":"f44b37ce5ecbb2a419ba7f490ac4f31f50f2ecf7a39085c99270ace81519d683","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-868.5590","next":"us/21-cfr-868.5620"},"notice":"GroundRules: Original legal text. Not legal advice."}