C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 868—ANESTHESIOLOGY DEVICES › Subpart F—Therapeutic Devices

21 C.F.R. § 868.5580

Oxygen mask

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(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]
Notes of Decisions
Cited in 3 cases, 1997–1999 · leading case: Sita v. Danek Med., Inc., 43 F. Supp. 2d 245 (E.D.N.Y 1999).
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Sita v. Danek Med., Inc., 43 F. Supp. 2d 245 (E.D.N.Y 1999). “§ 360e(a)(l)(B); 21 C.F.R. §§ 868.5580 , 880.5570 (1993). Class III devices are those which “present a potential unreasonable risk of illness or injury.”
Coyne Beahm, Inc. v. United States Food & Drug Admin., 966 F. Supp. 1374 (M.D.N.C. 1997). “5570 (hypodermic needle that delivers drug substance to site on body); 21 C.F.R. § 868.5580 (oxygen mask that delivers oxygen for absorption by the lungs).”
Coyne Beahm, Inc. v. United States Food & Drug Admin., 958 F. Supp. 1060 (M.D.N.C. 1997). “5570 (hypodermic needle that delivers drug substance to site on body); 21 C.F.R. § 868.5580 (oxygen mask that delivers oxygen for absorption by the lungs).”
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