Emergency Resuscitator

QOU · Not classified · Unknown

Classification

FDA Product Code: QOU
Device class: Not classified
Regulation: —
Review panel: AN
Medical specialty: Unknown
Submission type: 8
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Emergency ventilator incorporating bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway (may be automated) for use during declared public health emergency.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

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