FDA.report

510(k) K203142

Device
Veuron-Brain-pAb
Applicant
Heuron Co., Ltd.
510(k) number
K203142
Product code
LLZ  
Decision
Substantially Equivalent (SESE)
Decision date
2021-01-15
Date received
2020-10-20
Regulation
892.2050
Classification name
System, Image Processing, Radiological
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Dong Hoon Shin
Address
10th Floor, 7, Mirae-Ro, Namdong-Gu Incheon KR 21558 21558

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
08800086200026Veuron-Brain-pAbHeuron Co.,Ltd.2021-11-09

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Legacy Summary

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FDA Review

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