Suction Anti-Choking Device As A Second-Line Treatment

QXN · Class II — Moderate Risk (510(k) clearance required) · Ear, Nose, Throat · 21 CFR 874.5400

Classification

FDA Product Code: QXN
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 874.5400
Review panel: EN
Medical specialty: Ear, Nose, Throat
Submission type: 1
GMP exempt: N
Life sustaining: Y
Implant: N
Third-party review: N

Definition

A suction anti-choking device as a second-line treatment is intended to be used, by application of suction, to resolve choking in victims experiencing complete airway obstruction. The device is intended to be used as a second-line treatment in an emergency situation after unsuccessful use of a basic life support (BLS) choking protocol.

Market data

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

Source

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