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Medical Devices; Neurological Devices; Classification of the Evoked Photon Image Capture Device. Final order
Federal Register
|October 12, 2016
Abstract:
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.
