NRH
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- System, Breath Measurement
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1820
- Medical specialty
- Clinical Chemistry
- FDA definition
- Breath measurement systems are used to measure constituents of exhaled breath as an aid in the diagnosis of sugar/nutrient malabsorbtion and other conditions.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY (K033688) | Micro Direct, Inc. | 2004-05-19 |
| MICRO H2 (K963376) | Micro Direct, Inc. | 1997-01-24 |
| JAYCO HYDROGEN MONITOR (K882499) | Enteron, Inc. | 1988-06-28 |
| VITALOGRAPH-EC60 HYDROGEN MONITOR (K874892) | Vitalograph , Ltd. | 1988-06-02 |
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