ULTRASOUND LOCALIZATION SYSTEM ULS 0142— 510(k) K040741

Name: FDA 510(k) clearance K040741
Creator: U.S. Food and Drug Administration
Published: 2004-08-19

Substantially Equivalent

Hmt High Medical Technologies AG

FDA 510(k) clearance K040741 for ULTRASOUND LOCALIZATION SYSTEM ULS 0142, Substantially Equivalent on 2004-08-19. Applicant: Hmt High Medical Technologies AG. Device class: 2.

Clearance details

Applicant: Hmt High Medical Technologies AG
Product code: Code LNS
Device class: Class 2
Regulation: 21 CFR 876.5990
Advisory panel: Gastroenterology, Urology
Date received: 2004-03-23
Decision date: 2004-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LNS

product code LNS

Death: 4
Injury: 320
Total: 324

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.