We now have FDA clearance
In order for medical devices to be legally marketed (sold) in the United States, they are required to be cleared or approved by the FDA unless it is 510(k) exempt. Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to (similar) another legally marketed device.
As of just a few days ago, Disposable Medical Instrument Ltd now have FDA clearance.
Tuesday, 2 April 2019 14:42:43 Europe/London
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