Document Detail


Medical devices; general hospital and personal use devices; classification of the intravascular administration set, automated air removal system. Final order.
MedLine Citation:
PMID:  24839665     Owner:  HSR     Status:  In-Process    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is classifying the intravascular administration set, automated air removal system 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 intravascular administration set, automated air removal system'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.
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  79     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2014 May 
Date Detail:
Created Date:  2014-05-19     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  28404-7     Citation Subset:  T    
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