FDA product code DMG: Papers, Ion
DMG is the FDA product code for papers, ion. It is a Class I device, regulated under 21 CFR 862.2230 and reviewed by the Clinical Toxicology panel. Devices under DMG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Papers, Ion |
| Device class | Class I |
| Regulation | 21 CFR 862.2230 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for DMG devices
openFDA lists no recalls for product code DMG.
Frequently asked questions
What is FDA product code DMG?
DMG is the FDA product code for papers, ion. It is a Class I device, regulated under 21 CFR 862.2230 and reviewed by the Clinical Toxicology panel.
What device class is DMG?
Class I, regulation 21 CFR 862.2230. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code DMG
- Run a recall and safety report across every DMG manufacturer
- Watch product code DMG 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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