510(k) K882499
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.