ULTRA-COVER PU-TRANSDUCER COVER— 510(k) K981069

Substantially Equivalent

International Medical Products B.V.

FDA 510(k) clearance K981069 for ULTRA-COVER PU-TRANSDUCER COVER, Substantially Equivalent on 1998-09-23. Applicant: International Medical Products B.V..

Clearance details

Applicant: International Medical Products B.V.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1998-03-24
Decision date: 1998-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zutphen, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.