Home / Device Classification / PHS

PHS — Oral Airway Assist Class I

FDA Device Classification

FDA product code PHS covers "Oral Airway Assist", a Class I medical device regulated under 21 CFR 868.5110. Submissions are reviewed by the Anesthesiology panel.

Classification Details

Product Code: PHS
Device Class: Class I
Regulation Number: 868.5110
Submission Type
Review Panel: AN
Medical Specialty: Anesthesiology
Implant: No

Definition

To assist in maintaining an open airway.