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GXS — Monitor, Alpha Class II

FDA Device Classification

FDA product code GXS covers "Monitor, Alpha", a Class II medical device regulated under 21 CFR 882.1610. Submissions are reviewed by the Neurology panel.

Classification Details

Product Code: GXS
Device Class: Class II
Regulation Number: 882.1610
Submission Type
Review Panel: NE
Medical Specialty: Neurology
Implant: No