FDA 510(k)

XN CHECK BF

K号: K160588 · 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 CHECK BF 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 K160588. 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 CHECK BF?

XN CHECK BF is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Streck. The 510(k) number is K160588.

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

XN CHECK BF received FDA 510(k) clearance on 2016-12-22, under 510(k) number K160588.

Who is the listed applicant for XN CHECK BF?

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 CHECK BF?

The FDA product code for XN CHECK BF 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 K160586XN-L 检查

查看所有 8 个设备 →

官方来源

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