{"data":{"id":"us/21-cfr-880.2900","jurisdiction":"us","citation":"21 CFR 880.2900","heading":"Clinical color change thermometer.","body":"(a) Identification. A clinical color change thermometer is a disposable device used to measure a patient's oral, rectal, or axillary (armpit) body temperature. The device records body temperature by use of heat sensitive chemicals which are sealed at the end of a plastic or metal strip. Body heat causes a stable color change in the heat sensitive chemicals.\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 § 880.9.","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 C—General Hospital and Personal Use Monitoring 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":"a2ccbdd758a4fe50408ff2face073c0c988064351ac770ea1c30f134de6641be","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-880.2800","next":"us/21-cfr-880.2910"},"notice":"GroundRules: Original legal text. Not legal advice."}