| Medical devices; neurological devices; classification of the Near Infrared Brain Hematoma Detector. Final rule. | |
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MedLine Citation:
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PMID: 22479734 Owner: HSR Status: In-Process |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA) is classifying the Near Infrared (NIR) Brain Hematoma Detector into class II (special controls). 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. |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Federal register Volume: 77 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 2012 Mar |
Date Detail:
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Created Date: 2012-04-05 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7808722 Medline TA: Fed Regist Country: United States |
Other Details:
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Languages: eng Pagination: 16925-7 Citation Subset: T |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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