Neuropsychiatric Interpretative Electroencephalograph Assessment Aid

NCG · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.1440

Classification

FDA Product Code: NCG
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.1440
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Uses a patient's electroencephalograph (EEG) to provide an interpretation of the patient's neuropsychiatric condition. It is also used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis."

Market data

Cleared 510(k) submissions: 3
Registered establishments: 1

Source

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