Clearance Summary
TX-2 THERMAL DILUTION CARDIAC OUTPUT received FDA 510(k) clearance under submission number K834408, sponsored by Waters Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1984-08-23.
- Submission: K834408
- Applicant / Sponsor: Waters Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1435
- Decision date: 1984-08-23
Classification & Regulation
This clearance is catalogued under FDA product code DXG and 21 CFR 870.1435, within the Cardiovascular review panel as a Class II device.