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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR868.5965]
See Related Information on Positive end expiratory pressure breathing attachment. in CDRH databases



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 F--Therapeutic Devices

Sec. 868.5965 Positive end expiratory pressure breathing attachment.

(a)Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.

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

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