Product code NRH

Device name

System, Breath Measurement

Medical specialty

Clinical Chemistry

Device class

1

Regulation number

862.1820

Review panel

CH

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

Breath measurement systems are used to measure constituents of exhaled breath as an aid in the diagnosis of sugar/nutrient malabsorbtion and other conditions.

Source

FDA openFDA device classification dataset