Clearance Summary
URI TX-100 MULTICHANNEL THERMOCOUPLE received FDA 510(k) clearance under submission number K843381, sponsored by Uri Therm-X, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1984-10-11.
- Submission: K843381
- Applicant / Sponsor: Uri Therm-X, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 1984-10-11
Classification & Regulation
This clearance is catalogued under FDA product code FLL and 21 CFR 880.2910, within the General Hospital review panel as a Class II device.