Document Detail


Medical devices; neurological devices; classification of the Near Infrared Brain Hematoma Detector. Final rule.
MedLine Citation:
PMID:  22479734     Owner:  HSR     Status:  In-Process    
Abstract/OtherAbstract:
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:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  77     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-04-05     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  16925-7     Citation Subset:  T    
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