K162190

Substantially Equivalent

Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)

Applicant: Villa Sistemi Medicali S.P.A.
Product code: MUH
Advisory panel: Dental
Date received: 2016-08-04
Decision date: 2017-07-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Buccinasco, IT

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