PORTABLE X-RAY SYSTEM— 510(k) K122124

Substantially Equivalent

Osstem Implant Co., Ltd.

FDA 510(k) clearance K122124 for PORTABLE X-RAY SYSTEM, Substantially Equivalent on 2013-05-16. Applicant: Osstem Implant Co., Ltd.. Device class: 2.

Clearance details

Applicant: Osstem Implant Co., Ltd.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2012-07-18
Decision date: 2013-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fariless Hills, PA, US

Download summary PDF View on FDA.gov ↗

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