R-Sensor, R-Sensor— 510(k) K200284

Substantially Equivalent

Remedi Co., Ltd.

FDA 510(k) clearance K200284 for R-Sensor, R-Sensor, Substantially Equivalent on 2020-02-28. Applicant: Remedi Co., Ltd.. Device class: 2.

Clearance details

Applicant: Remedi Co., Ltd.
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2020-02-05
Decision date: 2020-02-28
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.