FDA 510(k)

Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D和Stellaris 3D Ceph

K号: K213579 · 2022-03-02

决定日期2022-03-02

产品代码OAS

咨询委员会RA

决定实质等同

器械摘要

Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph is the device name listed in this FDA 510(k) record. The listed applicant is Fona S.R.L. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K213579. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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.

列明Fona S.R.L为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K222274FONA XDC K212103StarX-1，StarX-2，StarX PRO-1 和 StarX PRO-2 K161131FONA Pan/Ceph

官方来源

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