FDA 510(k)

XN-L 检查

K号: K160586 · 2016-12-22

申请人Streck

决定日期2016-12-22

产品代码JPK

咨询委员会HE 请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

XN-L CHECK is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K160586. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the XN-L CHECK?

XN-L CHECK is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Streck. The 510(k) number is K160586.

When did XN-L CHECK receive FDA 510(k) clearance?

XN-L CHECK received FDA 510(k) clearance on 2016-12-22, under 510(k) number K160586.

Who is the listed applicant for XN-L CHECK?

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

What is the FDA product code for XN-L CHECK?

The FDA product code for XN-L CHECK is JPK.

列明Streck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。

K254166MDx-Chex 用于 BCN K231223MDx-Chex 用于 BC-GN K231221MDx-Chex 用于 BC-GP K170091UA-Cellular 完整版 K160585XN 医疗设备 K160588XN CHECK BF

查看所有 8 个设备 →

官方来源

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