Humidifier, Respiratory, Mask (Direct Patient Interface)

OBN · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5450

Classification

FDA Product Code: OBN
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 868.5450
Review panel: AN
Medical specialty: Anesthesiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

Intended to moderate blood pressure in hypertensive patients when they are exposed to the cold. The mask attenuates (moderates) the physiological response, increases in blood pressure, associated with cold exposure, by warming the inhaled air during cold exposure for individuals with hypertension, medicated or non-medicated.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

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