{"data":{"id":"us/21-cfr-870.1435","jurisdiction":"us","citation":"21 CFR 870.1435","heading":"Single-function, preprogrammed diagnostic computer.","body":"(a) Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.\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 870—CARDIOVASCULAR DEVICES","Subpart B—Cardiovascular Diagnostic 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":"90ded6571b1e21d4f9359f5daf03b723886c6719a133b8b09f899294b00bd890","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-870.1425","next":"us/21-cfr-870.1450"},"notice":"GroundRules: Original legal text. Not legal advice."}