FDA product code MCK: Device, Voice Amplification
MCK is the FDA product code for device, voice amplification. It is a Class II device, regulated under 21 CFR 874.3730 and reviewed by the Ear, Nose and Throat panel. Devices under MCK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Device, Voice Amplification |
| Device class | Class II |
| Regulation | 21 CFR 874.3730 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Recalls for MCK devices
openFDA lists no recalls for product code MCK.
Frequently asked questions
What is FDA product code MCK?
MCK is the FDA product code for device, voice amplification. It is a Class II device, regulated under 21 CFR 874.3730 and reviewed by the Ear, Nose and Throat panel.
What device class is MCK?
Class II, regulation 21 CFR 874.3730. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code MCK
- Run a recall and safety report across every MCK manufacturer
- Watch product code MCK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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