R-Sensor, R-Sensor

System, X-ray, Extraoral Source, Digital

Remedi Co. Ltd.

The following data is part of a premarket notification filed by Remedi Co. Ltd. with the FDA for R-sensor, R-sensor.

Pre-market Notification Details

Device IDK200284
510k NumberK200284
Device Name:R-Sensor, R-Sensor
ClassificationSystem, X-ray, Extraoral Source, Digital
Applicant Remedi Co. Ltd. #1409, IS BIZ Tower, 26 Yangpyeong-ro 21 Seoul,  KR
ContactJadon Koo
CorrespondentW. Lee Strong
510K FDA Inc. 100 E Granada Blvd, Suite 219 Ormond Beach,  FL  32176
Product CodeMUH  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-05
Decision Date2020-02-28

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