FDA product code CCO: Bed, Rocking, Breathing Assist
CCO is the FDA product code for bed, rocking, breathing assist. It is a Class II device, regulated under 21 CFR 868.5180 and reviewed by the Anesthesiology panel. Devices under CCO reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Bed, Rocking, Breathing Assist |
| Device class | Class II |
| Regulation | 21 CFR 868.5180 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
| Life-sustaining or supporting | Yes |
Recalls for CCO devices
openFDA lists no recalls for product code CCO.
Frequently asked questions
What is FDA product code CCO?
CCO is the FDA product code for bed, rocking, breathing assist. It is a Class II device, regulated under 21 CFR 868.5180 and reviewed by the Anesthesiology panel.
What device class is CCO?
Class II, regulation 21 CFR 868.5180. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code CCO
- Run a recall and safety report across every CCO manufacturer
- Watch product code CCO 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.
All Anesthesiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times