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.