FDA product code PUH: Analyzer, Body Composition, Exempt
PUH is the FDA product code for analyzer, body composition, exempt. It is a Class II device, regulated under 21 CFR 870.2770 and reviewed by the Gastroenterology and Urology panel. Devices under PUH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code is the class II exempt counterpart of MNW, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Body Composition, Exempt |
| Device class | Class II |
| Regulation | 21 CFR 870.2770 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Recalls for PUH devices
openFDA lists no recalls for product code PUH.
Frequently asked questions
What is FDA product code PUH?
PUH is the FDA product code for analyzer, body composition, exempt. It is a Class II device, regulated under 21 CFR 870.2770 and reviewed by the Gastroenterology and Urology panel.
What device class is PUH?
Class II, regulation 21 CFR 870.2770. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PUH
- Run a recall and safety report across every PUH manufacturer
- Watch product code PUH 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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