Parkinsonian Syndrome Diagnostic Aid

SHO · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.2000

Classification

FDA Product Code: SHO
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.2000
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown