MCK — Device, Voice Amplification Class II

FDA Device Classification

FDA product code MCK covers "Device, Voice Amplification", a Class II medical device regulated under 21 CFR 874.3730. Submissions are reviewed by the Ear, Nose, Throat panel.

Classification Details

Product Code
MCK
Device Class
Class II
Regulation Number
874.3730
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No