{"data":{"id":"us/21-cfr-870.4340","jurisdiction":"us","citation":"21 CFR 870.4340","heading":"Cardiopulmonary bypass level sensing monitor and/or control.","body":"(a) Identification. A cardiopulmonary bypass level sensing monitor and/or control is a device used to monitor and/or control the level of blood in the blood reservoir and to sound an alarm when the level falls below a predetermined value.\n(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.","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 E—Cardiovascular Surgical 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":"05db4063174d76d3a4302595494c1af93fc29e31822b35f69f7c14f6e38c3749","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-870.4330","next":"us/21-cfr-870.4350"},"notice":"GroundRules: Original legal text. Not legal advice."}