FDA 510(k)

E-EEGX, N-EEGX

K号: K191322 · 2020-01-22

决定日期2020-01-22

产品代码OLT

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决定实质等同

器械摘要

E-EEGX, N-EEGX is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare Finland Oy. It received FDA 510(k) clearance on 2020-01-22 under 510(k) number K191322. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the E-EEGX, N-EEGX?

E-EEGX, N-EEGX is a medical device that received FDA 510(k) clearance on 2020-01-22. The listed applicant is GE Healthcare Finland Oy. The 510(k) number is K191322.

When did E-EEGX, N-EEGX receive FDA 510(k) clearance?

E-EEGX, N-EEGX received FDA 510(k) clearance on 2020-01-22, under 510(k) number K191322.

Who is the listed applicant for E-EEGX, N-EEGX?

FDA 510(k)记录显示GE Healthcare Finland Oy为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for E-EEGX, N-EEGX?

The FDA product code for E-EEGX, N-EEGX is OLT.

列明GE Healthcare Finland Oy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。

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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。

器械摘要

常见问题

列明GE Healthcare Finland Oy为申报人的其他记录

相关器械（代码：OLT）

官方来源