{"data":{"id":"us/21-cfr-868.2375","jurisdiction":"us","citation":"21 CFR 868.2375","heading":"Breathing frequency monitor.","body":"(a) Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.\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 868—ANESTHESIOLOGY DEVICES","Subpart C—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":"d7821838ea051f7561c720ebe98a63d01c785bf5626c4859f93463b09f619acd","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-868.2350","next":"us/21-cfr-868.2376"},"notice":"GroundRules: Original legal text. Not legal advice."}