Noninvasive Positive Airway Pressure System, Facility Use

SGR · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5895

Classification

FDA Product Code: SGR
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 868.5895
Review panel: AN
Medical specialty: Anesthesiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

To mechanically assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas through noninvasive continuous positive airway pressure.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 4

Source

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