K874892 is an FDA 510(k) clearance for the VITALOGRAPH-EC60 HYDROGEN MONITOR. This device is classified as a System, Breath Measurement (Class I - General Controls, product code NRH).
Submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on June 2, 1988, 184 days after receiving the submission on December 1, 1987.
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 | K874892 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 1987 |
| Decision Date | June 02, 1988 |
| Days to Decision | 184 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. |