Amplitude-Integrated Electroencephalograph

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

Classification

FDA Product Code: OMA
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

Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).

Market data

Cleared 510(k) submissions: 16
Registered establishments: 14

Source

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