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FDA Product Code

FDA Product Code NRH — Clearance Directory

Device Class
Class I
Assigned Panel
Clinical Chemistry
21 CFR Citation
862.1820

510(k) Clearances — 4 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K033688 MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY Micro Direct, Inc. 2004-05-19 Traditional PDF ↗
K963376 MICRO H2 Micro Direct, Inc. 1997-01-24 Traditional PDF ↗
K882499 JAYCO HYDROGEN MONITOR Enteron, Inc. 1988-06-28 Traditional PDF ↗
K874892 VITALOGRAPH-EC60 HYDROGEN MONITOR Vitalograph , Ltd. 1988-06-02 Traditional PDF ↗

Product code NRH · Class I · Clinical Chemistry. Data: openFDA.