Product code NRH— Clinical Chemistry

JAYCO HYDROGEN MONITOR

Classification name: System, Breath Measurement
Device class: Class 1
Regulation: 21 CFR 862.1820
Advisory panel: Clinical Chemistry
Total cleared: 4
First cleared: 1988-06-02
Most recent: 2004-05-19

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.”
— U.S. Food and Drug Administration, device classification record for product code NRH under 21 CFR 862.1820, via openFDA

Market context for product code NRH

FDA has cleared 4 devices under product code NRH between 1988 and 2004, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

20041 clearance
19971 clearance
19882 clearances

Top applicants under product code NRH

Micro Direct, Inc.2 clearances
Vitalograph , Ltd.1 clearance
Enteron, Inc.1 clearance

Recent clearances under product code NRH

K033688 — MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITYMicro Direct, Inc.·2004-05-19
K963376 — MICRO H2Micro Direct, Inc.·1997-01-24
K882499 — JAYCO HYDROGEN MONITOREnteron, Inc.·1988-06-28
K874892 — VITALOGRAPH-EC60 HYDROGEN MONITORVitalograph , Ltd.·1988-06-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.