Hybrid C70

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 C70.

Pre-market Notification Details

Device IDK220579
510k NumberK220579
Device Name:Hybrid C70
ClassificationUnit, X-ray, Extraoral With Timer
Applicant Digimed Co., Ltd 309-311, 318-ho 145, Gasan Digital 1-ro, Geumcheon-gu Seul,  KR 08506
ContactYoungbae Kwon
CorrespondentYoungbae Kwon
Digimed Co., Ltd 309-311, 318-ho 145, Gasan Digital 1-ro, Geumcheon-gu Seul,  KR 08506
Product CodeEHD  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-21
Decision Date2022-09-01

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.