{"data":{"id":"us/21-cfr-880.5400","jurisdiction":"us","citation":"21 CFR 880.5400","heading":"Neonatal incubator.","body":"(a) Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.\n(b) Classification. Class II (performance standards).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES","Subpart F—General Hospital and Personal Use 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":"ae753db72fdaf9e14b6c4ae4288dd58815677f6b851eda30951fabbac4419b5e","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-880.5300","next":"us/21-cfr-880.5405"},"notice":"GroundRules: Original legal text. Not legal advice."}