Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph— 510(k) K213579

Name: FDA 510(k) clearance K213579
Creator: U.S. Food and Drug Administration
Published: 2022-03-02

Substantially Equivalent

Fona S.R.L

FDA 510(k) clearance K213579 for Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph, Substantially Equivalent on 2022-03-02. Applicant: Fona S.R.L. Device class: 2.

Clearance details

Applicant: Fona S.R.L
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2021-11-10
Decision date: 2022-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Assago, IT

Download summary PDF View on FDA.gov ↗

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