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. § 868.5550

Anesthetic gas mask

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(a) Identification. An anesthetic gas mask is a device, usually made of conductive rubber, that is positioned over a patient's nose or mouth to direct anesthetic gases to the upper airway.

(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 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]
Notes of Decisions
Cited in 1 case, 1988–1988 · leading case: Tarallo v. Searle Pharm., Inc., 704 F. Supp. 653 (D.S.C. 1988).
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Tarallo v. Searle Pharm., Inc., 704 F. Supp. 653 (D.S.C. 1988). “21 C.F.R. §§ 868.5550 , 868.5580, 884.5460, 884.”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.