FDA 510(k)

Xeleris V 处理和审查系统

K号: K201103 · 2020-09-25

决定日期2020-09-25

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

Xeleris V Processing and Review Systems is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2020-09-25 under 510(k) number K201103. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Xeleris V Processing and Review Systems?

Xeleris V Processing and Review Systems is a medical device that received FDA 510(k) clearance on 2020-09-25. The listed applicant is GE Healthcare. The 510(k) number is K201103.

When did Xeleris V Processing and Review Systems receive FDA 510(k) clearance?

Xeleris V Processing and Review Systems received FDA 510(k) clearance on 2020-09-25, under 510(k) number K201103.

Who is the listed applicant for Xeleris V Processing and Review Systems?

The FDA 510(k) record lists GE Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xeleris V Processing and Review Systems?

The FDA product code for Xeleris V Processing and Review Systems is LLZ.

列明GE Healthcare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。

K253639查看此医疗设备监管文本： View the medical-device regulatory text for this device_name.K242925MR Contour DL K232346数字专家访问与远程扫描 K223212Precision DL K221680Xeleris V 处理与审查系统 K221932Omni 传奇

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官方来源

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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。