FDA product code NMB: Catheter, Oximeter, Fiber Optic, Reprocessed
NMB is the FDA product code for catheter, oximeter, fiber optic, reprocessed. It is a Class II device, regulated under 21 CFR 870.1230 and reviewed by the Cardiovascular panel. Devices under NMB reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Oximeter, Fiber Optic, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 870.1230 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Recalls for NMB devices
openFDA lists no recalls for product code NMB.
Frequently asked questions
What is FDA product code NMB?
NMB is the FDA product code for catheter, oximeter, fiber optic, reprocessed. It is a Class II device, regulated under 21 CFR 870.1230 and reviewed by the Cardiovascular panel.
What device class is NMB?
Class II, regulation 21 CFR 870.1230. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NMB
- Run a recall and safety report across every NMB manufacturer
- Watch product code NMB 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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