Product code SHO

Device name

Parkinsonian Syndrome Diagnostic Aid

Medical specialty

Neurology

Device class

2

Regulation number

882.2000

Review panel

NE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset