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FDA 510(k), K033688, MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY
FDA 510(k), K033688, MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY
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510(K) Number: K033688
Device Name: MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY
Manufacturer: MICRO DIRECT, INC.
Device Classification Name: System, Breath Measurement
Regulation Number: 862.1820
Classification Product Code: NRH
Date Received: 11/24/2003
Decision Date: 05/19/2004
Regulation Medical Specialty: Clinical Chemistry
Device Name: MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY
Manufacturer: MICRO DIRECT, INC.
Device Classification Name: System, Breath Measurement
Regulation Number: 862.1820
Classification Product Code: NRH
Date Received: 11/24/2003
Decision Date: 05/19/2004
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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