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..

Clearance details

Applicant: Rolence Enterprise, Inc.
Product code: Code EHD
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 ↗

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