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Zdrowie i gospodarka · 30.09.2016

Medical Devices; Neurological Devices; Classification of the Evoked Photon Image Capture Device

The Food and Drug Administration (FDA) is classifying the Evoked Photon Image Capture Device into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Source: Federal Register — Food and Drug AdministrationOpen original release →