NRH

System, Breath Measurement

Product code

NRH

Device name

System, Breath Measurement

Device class

Class 1

21 CFR

21 CFR 862.1820

Medical specialty

Clinical Chemistry

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).