FDA 510(k)

XVISION-525，地平线，HI-300，HI-500，土星-F PF32，土星-F PF40，土星-F PF50

K号: K230800 · 2023-11-02

决定日期2023-11-02

产品代码KPR

咨询委员会RA

决定实质等同

器械摘要

XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 is the device name listed in this FDA 510(k) record. The listed applicant is GEMSS HEALTHCARE CO., LTD.. It received FDA 510(k) clearance on 2023-11-02 under 510(k) number K230800. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50?

XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 is a medical device that received FDA 510(k) clearance on 2023-11-02. The listed applicant is GEMSS HEALTHCARE CO., LTD.. The 510(k) number is K230800.

When did XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 receive FDA 510(k) clearance?

XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 received FDA 510(k) clearance on 2023-11-02, under 510(k) number K230800.

Who is the listed applicant for XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50?

FDA 510(k)记录将GEMSS HEALTHCARE CO., LTD.列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50?

The FDA product code for XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 is KPR.

列明GEMSS HEALTHCARE CO., LTD.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。

K260236XLITE K233200XPLUS 35系列（XPLUS 35，XPLUS 35FD）

官方来源

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