Device For Sleep Apnea Testing Based On Mandibular Movement

QRS · Class II — Moderate Risk (510(k) clearance required) · Ear, Nose, Throat · 21 CFR 868.2376

Classification

FDA Product Code: QRS
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 868.2376
Review panel: AN
Medical specialty: Ear, Nose, Throat
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A device for sleep apnea testing based on mandibular movement is a prescription device intended to aid in evaluation of sleep apnea during sleep in patients suspected of having sleep breathing disorders by analyzing sensor readings of mandibular movement. The device is not intended as a substitute for full polysomnography nor intended to be used as an apnea monitor.

Market data

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

Source

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