Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)— 510(k) K201800

Name: FDA 510(k) clearance K201800
Creator: U.S. Food and Drug Administration
Published: 2020-12-28

Substantially Equivalent

Nanoray Co., Ltd.

FDA 510(k) clearance K201800 for Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X), Substantially Equivalent on 2020-12-28. Applicant: Nanoray Co., Ltd.. Device class: 2.

Clearance details

Applicant: Nanoray Co., Ltd.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2020-06-30
Decision date: 2020-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, KR

Download summary PDF View on FDA.gov ↗

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