MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY— 510(k) K033688
Substantially EquivalentMicro Direct, Inc.
FDA 510(k) clearance K033688 for MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY, Substantially Equivalent on 2004-05-19. Applicant: Micro Direct, Inc.. Device class: 1.
Clearance details
- Applicant
- Micro Direct, Inc.
- Product code
- Code NRH
- Device class
- Class 1
- Regulation
- 21 CFR 862.1820
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lewiston, ME, US
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