ELEC Master, ELEC Master Dual— 510(k) K202963

Substantially Equivalent

Mgnewton , Ltd.

FDA 510(k) clearance K202963 for ELEC Master, ELEC Master Dual, Substantially Equivalent on 2023-05-05. Applicant: Mgnewton , Ltd.. Device class: 1.

Clearance details

Applicant: Mgnewton , Ltd.
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2020-09-30
Decision date: 2023-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeongsan-Si, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.