510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OZKClass II

Thermometer, Exhaled Breath

21 CFR 880.2910 / General Hospital
FDA source (opens on fda.gov)

OZK is the FDA product code for Thermometer, Exhaled Breath, a class II device type, regulated under 21 CFR 880.2910. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OZK
Device name
Thermometer, Exhaled Breath
FDA 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.
Regulation
21 CFR 880.2910
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OZK.