System, Breath Measurement
Device Code: 638
Product Code(s):
NRH 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.
Device Classification Information
| Device Type ID | 638 |
| Device Name | System, Breath Measurement |
| Regulation Description | Xylose Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.1820 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NRH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 638 |
| Device | System, Breath Measurement |
| Product Code | NRH |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Xylose Test System. |
| CFR Regulation Number | 862.1820 [🔎] |
TPLC Last Update: 2019-04-02 19:37:56