TaiChiC

System, Radiation Therapy, Radionuclide

Our United Corporation

The following data is part of a premarket notification filed by Our United Corporation with the FDA for Taichic.

Pre-market Notification Details

Device IDK203250
510k NumberK203250
Device Name:TaiChiC
ClassificationSystem, Radiation Therapy, Radionuclide
Applicant Our United Corporation Room 10301, 3rd Floor, Unit 1, Block 28, ShouChuang International Business Center, No.66 Xi'an,  CN 710018
ContactQi Liu
CorrespondentQi Liu
Our United Corporation Room 10301, 3rd Floor, Unit 1, Block 28, ShouChuang International Business Center, No.66 Xi'an,  CN 710018
Product CodeIWB  
CFR Regulation Number892.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-04
Decision Date2021-03-12

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