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PGJ — Oximeter, Wellness Class II

FDA Device Classification

FDA product code PGJ covers "Oximeter, Wellness", a Class II medical device regulated under 21 CFR 870.2700. Submissions are reviewed by the Cardiovascular panel.

Classification Details

Product Code: PGJ
Device Class: Class II
Regulation Number: 870.2700
Submission Type
Review Panel: AN
Medical Specialty: Cardiovascular
Implant: No

Definition

Pulse oximeter intended for wellness use.