Business & Finance
510k filed with FDA for ultrasound biomicroscope, company financials reported
Published in Medical Letter on the CDC and FDA, May 29th, 2005
The company was recently awarded the CE Mark for the P60 UBM, which will enable it to market the device in 19 Western European countries and some parts of the Pacific Rim.
A 510(k) is a formal marketing application to the FDA to gain clearance for specific indications of use for a device. With FDA approval, the new device will be available for sale in the United States.
"The P60 represents the latest generation of our UBM devices," said...
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