Thermometer, Exhaled Breath

OZK · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.2910

Classification

FDA Product Code: OZK
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.2910
Review panel: HO
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

To measure the temperature of exhaled human breath, which is frequently increased in airway inflammation in asthma patients. Measurement of changes in exhaled human breath temperature aids in evaluating airway inflammation treatment in asthma patients as an adjunct to established clinical and laboratory assessments of asthma.

Market data

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

Source

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