FDA product code NHO: Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
NHO is the FDA product code for analyzer, gas, desflurane, gaseous-phase (anesthetic concentration). It is a Class II device, regulated under 21 CFR 868.1500 and reviewed by the Anesthesiology panel. Devices under NHO reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
A desflurane gas analyzer is a device intended to measure the concentration of desflurane anesthetic in a gas mixture.
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) |
| Device class | Class II |
| Regulation | 21 CFR 868.1500 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NHO devices
openFDA lists no recalls for product code NHO.
Frequently asked questions
What is FDA product code NHO?
NHO is the FDA product code for analyzer, gas, desflurane, gaseous-phase (anesthetic concentration). It is a Class II device, regulated under 21 CFR 868.1500 and reviewed by the Anesthesiology panel.
What device class is NHO?
Class II, regulation 21 CFR 868.1500. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NHO
- Run a recall and safety report across every NHO manufacturer
- Watch product code NHO 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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