Portable X-ray System— 510(k) K172928

Substantially Equivalent

Rolence Enterprise, Inc.

FDA 510(k) clearance K172928 for Portable X-ray System, Substantially Equivalent on 2018-03-16. Applicant: Rolence Enterprise, Inc.. Device class: 2.

Clearance details

Applicant: Rolence Enterprise, Inc.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2017-09-25
Decision date: 2018-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taoyuan, TW

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.