FDA product code HBK: Chair, Pneumoencephalographic
HBK is the FDA product code for chair, pneumoencephalographic. It is a Class II device, regulated under 21 CFR 892.1820 and reviewed by the Radiology panel. Devices under HBK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Chair, Pneumoencephalographic |
| Device class | Class II |
| Regulation | 21 CFR 892.1820 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Recalls for HBK devices
openFDA lists no recalls for product code HBK.
Frequently asked questions
What is FDA product code HBK?
HBK is the FDA product code for chair, pneumoencephalographic. It is a Class II device, regulated under 21 CFR 892.1820 and reviewed by the Radiology panel.
What device class is HBK?
Class II, regulation 21 CFR 892.1820. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HBK
- Run a recall and safety report across every HBK manufacturer
- Watch product code HBK 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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