Clearance Summary
UROSURGE UROTHERM FLUID WARMING SYSTEM received FDA 510(k) clearance under submission number K965136, sponsored by Princeton Regulatory Assoc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1998-10-16.
- Submission: K965136
- Applicant / Sponsor: Princeton Regulatory Assoc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5950
- Decision date: 1998-10-16
Classification & Regulation
This clearance is catalogued under FDA product code LHC and 21 CFR 890.5950, within the Physical Medicine review panel as a Class I device.