Ventilatory Assistance Helmet

QOW · Not classified · Unknown

Classification

FDA Product Code: QOW
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

Patient interface for delivery of positive pressure to assist patient's breathing during declared public health emergency. Can be used with continuous and non-continuous ventilators, wall gas source, oxygen source, humidified gases.

Market data

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

Source

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