21 CFR 868.5100 — Airway, Nasopharyngeal

Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5100

Identification

A nasopharyngeal airway is a device used to aid breathing by means of a tube inserted into a patient's pharynx through the nose to provide a patent airway.

Classification Rationale

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
BTQAirway, Nasopharyngeal119
Innolitics

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