FDA 510(k)

FONA XDC

K号: K222274 · 2022-08-23

决定日期2022-08-23

产品代码EHD

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决定实质等同

器械摘要

FONA XDC 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 2022-08-23 under 510(k) number K222274. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FONA XDC?

FONA XDC is a medical device that received FDA 510(k) clearance on 2022-08-23. The listed applicant is Fona S.R.L. The 510(k) number is K222274.

When did FONA XDC receive FDA 510(k) clearance?

FONA XDC received FDA 510(k) clearance on 2022-08-23, under 510(k) number K222274.

Who is the listed applicant for FONA XDC?

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 FONA XDC?

The FDA product code for FONA XDC is EHD.

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。

K213579Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D和Stellaris 3D Ceph K212103StarX-1，StarX-2，StarX PRO-1 和 StarX PRO-2 K161131FONA Pan/Ceph

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

器械摘要

常见问题

列明Fona S.R.L为申报人的其他记录

相关器械（代码：EHD）

官方来源