RCT800— 510(k) K192737

Substantially Equivalent

Ray Co., Ltd.

FDA 510(k) clearance K192737 for RCT800, Substantially Equivalent on 2019-10-22. Applicant: Ray Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ray Co., Ltd.
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2019-09-27
Decision date: 2019-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

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