The MyLab™40 Family, manufactured by Esaote, complies with the Medical Device Directive (MDD) 93\42\EEC. In accordance with this directive, Esaote has classified it as Class IIa devices.
The MyLab™40 Family ultrasound imaging systems have been cleared by the Food and Drug Administration (FDA) via 510(k).
Technology and features are system/configuration dependent. Specifications subject to change without notice.
Information might refer to products or modalities not yet approved in all countries.
For further details, please contact your Esaote sales representative.