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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal MH9-0097851-0/1/1

Manufacturer FEI3003307657
Manufacturer NameNingbo David Medical Device Co.,Ltd  
Manufacturer Address line 1No 158 Daqing Rd  
Manufacturer Address line 2  
Manufacturer's CityShipu Ningbo  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code80KMI  
FDA Product DescriptionMONITOR, BED PATIENT  
Refusal Date17-Nov-2011  
FDA DistrictFLA-DO  
Entry/doc/line/sfx MH9-0097851-0/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
REGISTERED   502(o), 801(a)(3); MISBRANDING   It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).