UniWeb 8.0

System, Image Processing, Radiological

EBM Technologies Incorporated

The following data is part of a premarket notification filed by Ebm Technologies Incorporated with the FDA for Uniweb 8.0.

Pre-market Notification Details

Device IDK142514
510k NumberK142514
Device Name:UniWeb 8.0
ClassificationSystem, Image Processing, Radiological
Applicant EBM Technologies Incorporated 5F., No. 516, Sec. 1, Neihu Rd., Neihu Dist. Taipei,  TW
ContactJohn Su
CorrespondentJohn Su
EBM Technologies Incorporated 5F., No. 516, Sec. 1, Neihu Rd., Neihu Dist. Taipei,  TW
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-08
Decision Date2014-12-18

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