federal_register: 2016-23633

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2016-23633 Medical Devices; Neurological Devices; Classification of the Evoked Photon Image Capture Device Rule 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. 2016-09-30 2016 9 https://www.federalregister.gov/documents/2016/09/30/2016-23633/medical-devices-neurological-devices-classification-of-the-evoked-photon-image-capture-device https://www.govinfo.gov/content/pkg/FR-2016-09-30/pdf/2016-23633.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...

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