Cocoon Portable Handheld X-Ray System— 510(k) K173046

Name: FDA 510(k) clearance K173046
Creator: U.S. Food and Drug Administration
Published: 2017-10-26

Substantially Equivalent

Dexcowin Co., Ltd.

FDA 510(k) clearance K173046 for Cocoon Portable Handheld X-Ray System, Substantially Equivalent on 2017-10-26. Applicant: Dexcowin Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dexcowin Co., Ltd.
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2017-09-28
Decision date: 2017-10-26
Decision: Substantially Equivalent
Clearance type: Special
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.