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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, 2009]
[CITE: 21CFR868.5580]
 See Related Information on 868.5580 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. 868.5580 Oxygen mask.

(a)Identification. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]

 
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