Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph
K-Number: K213579 · 2022-03-02
Device Summary
Frequently Asked Questions
What is the Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph?
Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Fona S.R.L. The 510(k) number is K213579.
When did Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph receive FDA 510(k) clearance?
Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph received FDA 510(k) clearance on 2022-03-02, under 510(k) number K213579.
Who is the listed applicant for Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph?
The FDA 510(k) record lists Fona S.R.L as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph?
The FDA product code for Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph is OAS.
Other records listing Fona S.R.L as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: OAS)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.