FDA product code DRZ: Oscillometer
DRZ is the FDA product code for oscillometer. It is a Class II device, regulated under 21 CFR 870.2675 and reviewed by the Cardiovascular panel. Devices under DRZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Oscillometer |
| Device class | Class II |
| Regulation | 21 CFR 870.2675 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Recalls for DRZ devices
openFDA lists no recalls for product code DRZ.
Frequently asked questions
What is FDA product code DRZ?
DRZ is the FDA product code for oscillometer. It is a Class II device, regulated under 21 CFR 870.2675 and reviewed by the Cardiovascular panel.
What device class is DRZ?
Class II, regulation 21 CFR 870.2675. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code DRZ
- Run a recall and safety report across every DRZ manufacturer
- Watch product code DRZ 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.