rainbow MCT— 510(k) K200270

Substantially Equivalent

Dentium Co., Ltd (Ict Branch)

FDA 510(k) clearance K200270 for rainbow MCT, Substantially Equivalent on 2021-04-16. Applicant: Dentium Co., Ltd (Ict Branch). Device class: 2.

Clearance details

Applicant: Dentium Co., Ltd (Ict Branch)
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2020-02-04
Decision date: 2021-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

Download summary PDF View on FDA.gov ↗

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