EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i— 510(k) K151707

Name: FDA 510(k) clearance K151707
Creator: U.S. Food and Drug Administration
Published: 2015-07-19

Substantially Equivalent

Rayence Co., Ltd.

FDA 510(k) clearance K151707 for EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i, Substantially Equivalent on 2015-07-19. Applicant: Rayence Co., Ltd.. Device class: 2.

Clearance details

Applicant: Rayence Co., Ltd.
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2015-06-24
Decision date: 2015-07-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

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