EQ-M

Handpiece, Direct Drive, Ac-powered

Meta Systems Co., Ltd

The following data is part of a premarket notification filed by Meta Systems Co., Ltd with the FDA for Eq-m.

Pre-market Notification Details

Device IDK210475
510k NumberK210475
Device Name:EQ-M
ClassificationHandpiece, Direct Drive, Ac-powered
Applicant Meta Systems Co., Ltd #1214-18, Sicox Tower 12F, 484, Dunchon-daero, Jungwon-gu Seongnam-si,  KR 13229
ContactYang Ho Dong
CorrespondentYang Ho Dong
Onbix Corporation #821 Samil Plaza, 14 Dogok-ro 1-gil, Gangnam-gu Seoul,  KR 06253
Product CodeEKX  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-17
Decision Date2022-09-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809455601952 K210475 000
08809455601945 K210475 000
08809455601938 K210475 000
08809455601921 K210475 000
08809455601402 K210475 000
08809455600917 K210475 000

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