870.4410—Cardiopulmonary bypass in-line blood gas sensor. - Title 21 - Food and Drugs CFR - USA Laws Searching

CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 870—CARDIOVASCULAR DEVICES > SUBPART E—Cardiovascular Surgical Devices (§870.4075 to §870.4885) > 870.4410—Cardiopulmonary bypass in-line blood gas sensor.

870.4410—Cardiopulmonary bypass in-line blood gas sensor.

(a) Identification. A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood.

(b) Classification. Class II (performance standards).