Clearance Summary
ULTRASOUND LOCALIZATION SYSTEM ULS 0142 received FDA 510(k) clearance under submission number K040741, sponsored by Hmt High Medical Technologies AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2004-08-19.
- Submission: K040741
- Applicant / Sponsor: Hmt High Medical Technologies AG
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5990
- Decision date: 2004-08-19
Classification & Regulation
This clearance is catalogued under FDA product code LNS and 21 CFR 876.5990, within the Gastroenterology, Urology review panel as a Class II device.