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

21 CFR 868.5690: Incentive spirometer.

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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 868—ANESTHESIOLOGY DEVICES
  5. Subpart F—Therapeutic Devices

(a) Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.

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

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

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