GuideMia Ortho+— 510(k) K162850

Substantially Equivalent

Guidemia Technologies, LLC

FDA 510(k) clearance K162850 for GuideMia Ortho+, Substantially Equivalent on 2017-03-24. Applicant: Guidemia Technologies, LLC. Device class: 2.

Clearance details

Applicant: Guidemia Technologies, LLC
Product code: Code PNN
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2016-10-11
Decision date: 2017-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Alamitos, CA, 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.