MYLAB40— 510(k) K070903

Substantially Equivalent

Esaote Europe B.V.

FDA 510(k) clearance K070903 for MYLAB40, Substantially Equivalent on 2007-07-02. Applicant: Esaote Europe B.V..

Clearance details

Applicant: Esaote Europe B.V.
Product code: Code ITX
Advisory panel: Radiology
Date received: 2007-04-02
Decision date: 2007-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmel, IN, US

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.