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USA FDA 510(k) Clearances

Moor Instruments are proud to announce the FDA clearance of two more of its products, the moorVMS-OXY tissue oxygen and temperature monitor and the moorFLPI-2 full-field, video frame rate blood flow imager.

This clearance allows Moor Instruments' customer to freely use both systems in the USA without any IRB exemptions.

The relating 510(k) numbers are: -

moorVMS-OXY - K112826

moorFLPI-2 - K122943

Other products already with USA FDA 510(k) clearance include the moorLDI2-BI burn assessment system alongside the following products;

DRT4 - 510(k) Number K011070
moorLDI - 510(k) Number K980383
moorLDI-IR - 510(k) Number K032841
moorLDI2-BI - 510(k) Number K060976
moorLDLS - 510(k) Number K063561
moorFLPI - 510(k) Number K063586
moorVMS-LDF1 & moorVMS-LDF2 - 510(k) Number K083082
moorVMS-PRES - 510(k) Number K102433
moorVMS-OXY - 510(k) Number K112826

For further information or to arrange a no-obligation loan of any of our products, please contact us.