Automatic Event Detection Software For Polysomnograph With Electroencephalograph

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

Classification

FDA Product Code: OLZ
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: N

Definition

Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user

Market data

Cleared 510(k) submissions: 36
Registered establishments: 25

Source

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