OPTEO, VIDEOGRAPH HD— 510(k) K133271

Substantially Equivalent

Owandy

FDA 510(k) clearance K133271 for OPTEO, VIDEOGRAPH HD, Substantially Equivalent on 2014-04-28. Applicant: Owandy. Device class: 2.

Clearance details

Applicant: Owandy
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2013-10-24
Decision date: 2014-04-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Ormond Beach, FL, 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.