Full-Montage Standard Electroencephalograph

GWQ · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.1400

Classification

FDA Product Code: GWQ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.1400
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

Market data

Cleared 510(k) submissions: 188
Registered establishments: 98

Source

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