K882499 is an FDA 510(k) clearance for the JAYCO HYDROGEN MONITOR. This device is classified as a System, Breath Measurement (Class I - General Controls, product code NRH).
Submitted by Enteron, Inc. (Camp Hill, US). The FDA issued a Cleared decision on June 28, 1988, 11 days after receiving the submission on June 17, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1820. Breath Measurement Systems Are Used To Measure Constituents Of Exhaled Breath As An Aid In The Diagnosis Of Sugar/nutrient Malabsorbtion And Other Conditions..
| 510(k) Number | K882499 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 1988 |
| Decision Date | June 28, 1988 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | NRH — System, Breath Measurement |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1820 |
| 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. |