NRH · Class I · 21 CFR 862.1820

FDA Product Code NRH: System, Breath Measurement

Breath Measurement Systems Are Used To Measure Constituents Of Exhaled Breath As An Aid In The Diagnosis Of Sugar/nutrient Malabsorbtion And Other Conditions.

Leading manufacturers include Micro Direct, Inc. and Vitalograph , Ltd..

4
Total
4
Cleared
131d
Avg days
1988
Since

FDA 510(k) Cleared System, Breath Measurement Devices (Product Code NRH)

4 devices
1–4 of 4
Cleared May 19, 2004
MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY
K033688
Micro Direct, Inc.
Chemistry · 177d
Cleared Jan 24, 1997
MICRO H2
K963376
Micro Direct, Inc.
Chemistry · 150d
Cleared Jun 02, 1988
VITALOGRAPH-EC60 HYDROGEN MONITOR
K874892
Vitalograph , Ltd.
Chemistry · 184d

About Product Code NRH - Regulatory Context