Positive Airway Pressure System

QBY · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5273

Classification

FDA Product Code: QBY
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 868.5273
Review panel: AN
Medical specialty: Anesthesiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A positive airway pressure delivery system is a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 1

Source

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