PORTABLE X-RAY SYSTEM— 510(k) K103600

Substantially Equivalent

Digimed Corporation

FDA 510(k) clearance K103600 for PORTABLE X-RAY SYSTEM, Substantially Equivalent on 2011-04-08. Applicant: Digimed Corporation. Device class: 2.

Clearance details

Applicant: Digimed Corporation
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2010-12-08
Decision date: 2011-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo Grove, IL, 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.