FDA product code OSZ: Antimicrobial Keyboard
OSZ is the FDA product code for antimicrobial keyboard. It is a Class II device, regulated under 21 CFR 880.6600 and reviewed by the General Hospital panel. Devices under OSZ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
To reduce microbial populations
Classification
| Field | Value |
|---|---|
| Device name | Antimicrobial Keyboard |
| Device class | Class II |
| Regulation | 21 CFR 880.6600 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for OSZ devices
openFDA lists no recalls for product code OSZ.
Frequently asked questions
What is FDA product code OSZ?
OSZ is the FDA product code for antimicrobial keyboard. It is a Class II device, regulated under 21 CFR 880.6600 and reviewed by the General Hospital panel.
What device class is OSZ?
Class II, regulation 21 CFR 880.6600. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OSZ
- Run a recall and safety report across every OSZ manufacturer
- Watch product code OSZ 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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