MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY

MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY is an FDA 510(k)-cleared medical device (K033688) manufactured by Micro Direct, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 18, 2004. Regulation: 8.