FDA.report

510(k) K121788

Device
NIO 5MP
Applicant
BARCO NV
510(k) number
K121788
Product code
LLZ  
Decision
Substantially Equivalent (SESE)
Decision date
2012-07-23
Date received
2012-06-18
Regulation
892.2050
Classification name
System, Image Processing, Radiological
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
LIEVEN DE WANDEL
Address
35 President Kennedypark Kortrijk BE

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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