510(k) K882499
K882499 is an FDA 510(k) premarket notification submitted by Enteron, Inc. for the device "JAYCO HYDROGEN MONITOR". The FDA issued a decision of Substantially Equivalent on June 28, 1988. The device falls under product code NRH (System, Breath Measurement), a Class I device regulated under 21 CFR 862.1820.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 1988
- Date Received
- June 17, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Breath Measurement
- Device Class
- Class I
- Regulation Number
- 862.1820
- Review Panel
- CH
- Submission Type
Breath measurement systems are used to measure constituents of exhaled breath as an aid in the diagnosis of sugar/nutrient malabsorbtion and other conditions.