HYBRID S70

Unit, X-ray, Extraoral With Timer

Digimed Co., LTD.

The following data is part of a premarket notification filed by Digimed Co., Ltd. with the FDA for Hybrid S70.

Pre-market Notification Details

Device IDK220574
510k NumberK220574
Device Name:HYBRID S70
ClassificationUnit, X-ray, Extraoral With Timer
Applicant Digimed Co., LTD. 145, Gasan Digital 1-ro, Geumcheon-gu Seoul,  KR 08506
ContactYoungbae Kwon
CorrespondentYoungbae Kwon
Digimed Co., LTD. 145, Gasan Digital 1-ro, Geumcheon-gu Seoul,  KR 08506
Product CodeEHD  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-28
Decision Date2022-04-22

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