Clearance Summary
MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY received FDA 510(k) clearance under submission number K033688, sponsored by Micro Direct, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2004-05-19.
- Submission: K033688
- Applicant / Sponsor: Micro Direct, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1820
- Decision date: 2004-05-19
Classification & Regulation
This clearance is catalogued under FDA product code NRH and 21 CFR 862.1820, within the Clinical Chemistry review panel as a Class I device.