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Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 870.4330: Cardiopulmonary bypass on-line blood gas monitor.

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Where this section sits in the code
  1. Title 21—Food and Drugs
  2. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  3. SUBCHAPTER H—MEDICAL DEVICES
  4. PART 870—CARDIOVASCULAR DEVICES
  5. Subpart E—Cardiovascular Surgical Devices

(a) Identification. A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.

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

Collected 2026-08-27T02:24:47Z. Source file · JSON

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