EMS-200— 510(k) K153285

Substantially Equivalent

Meta Systems Co., Ltd.

FDA 510(k) clearance K153285 for EMS-200, Substantially Equivalent on 2016-08-12. Applicant: Meta Systems Co., Ltd.. Device class: 1.

Clearance details

Applicant: Meta Systems Co., Ltd.
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2015-11-12
Decision date: 2016-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, 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.