federal_register: 2015-07010

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2015-07010 Medical Devices; Neurological Devices; Classification of the Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid Rule The Food and Drug Administration (FDA) is classifying the brain injury adjunctive interpretive electroencephalograph assessment aid into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the brain injury adjunctive interpretive electroencephalograph assessment aid's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. 2015-03-27 2015 3 https://www.federalregister.gov/documents/2015/03/27/2015-07010/medical-devices-neurological-devices-classification-of-the-brain-injury-adjunctive-interpretive https://www.govinfo.gov/content/pkg/FR-2015-03-27/pdf/2015-07010.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is classifying the brain injury adjunctive interpretive electroencephalograph assessment aid into class II (special controls). The special controls that will apply to the device are identified in this order and...  

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