NRH — System, Breath Measurement Class I
FDA product code NRH covers "System, Breath Measurement", a Class I medical device regulated under 21 CFR 862.1820. Submissions are reviewed by the Clinical Chemistry panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NRH
- Device Class
- Class I
- Regulation Number
- 862.1820
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K033688 | micro direct | MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY | May 19, 2004 |
| K963376 | micro direct | MICRO H2 | January 24, 1997 |
| K882499 | enteron | JAYCO HYDROGEN MONITOR | June 28, 1988 |
| K874892 | vitalograph | VITALOGRAPH-EC60 HYDROGEN MONITOR | June 2, 1988 |