FDA product code SHO: Parkinsonian Syndrome Diagnostic Aid
SHO is the FDA product code for parkinsonian syndrome diagnostic aid. It is a Class II device, regulated under 21 CFR 882.2000 and reviewed by the Neurology panel. Devices under SHO reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A Parkinsonian syndrome diagnostic aid is a prescription device that analyzes patient-specific data to aid in the diagnosis of Parkinsonian syndromes. This device is intended for adjunctive use and not intended as a stand-alone diagnostic.
Classification
| Field | Value |
|---|---|
| Device name | Parkinsonian Syndrome Diagnostic Aid |
| Device class | Class II |
| Regulation | 21 CFR 882.2000 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Recalls for SHO devices
openFDA lists no recalls for product code SHO.
Frequently asked questions
What is FDA product code SHO?
SHO is the FDA product code for parkinsonian syndrome diagnostic aid. It is a Class II device, regulated under 21 CFR 882.2000 and reviewed by the Neurology panel.
What device class is SHO?
Class II, regulation 21 CFR 882.2000. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SHO
- Run a recall and safety report across every SHO manufacturer
- Watch product code SHO 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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