FDA 510(k)

Tablo控制台

K号: K160881 · 2016-11-15

决定日期2016-11-15

产品代码KDI

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

Tablo Console is the device name listed in this FDA 510(k) record. The listed applicant is Outset Medical, Inc.. It received FDA 510(k) clearance on 2016-11-15 under 510(k) number K160881. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tablo Console?

Tablo Console is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Outset Medical, Inc.. The 510(k) number is K160881.

When did Tablo Console receive FDA 510(k) clearance?

Tablo Console received FDA 510(k) clearance on 2016-11-15, under 510(k) number K160881.

Who is the listed applicant for Tablo Console?

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

What is the FDA product code for Tablo Console?

The FDA product code for Tablo Console is KDI.

列明Outset Medical, Inc.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。

K253412Tablo血液透析系统（PN-0008000，PN-0006000U）K232776Tablo® 血液透析系统；TabloCart™ 带预过滤抽屉 K233335Tablo® 血液透析系统 K223248Tablo® 血液透析系统 K211370Tablo血液透析系统 K210782Tablo药盒

查看所有 9 个设备 →

相关器械（代码：KDI）

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。

K261267Careflux H60；Careflux H70；Careflux V500Fresenius Medical Care Renal Therapies Group, LLC K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC K260533ELISIO™-HNipro Medical Corporation K252459multiFlux 130（F00013123）；multiFlux 160（F00013124）Fresenius Medical Care Renal Therapies Group, LLC K253412Tablo血液透析系统（PN-0008000，PN-0006000U）Outset Medical, Inc.K253518FX CorAL 40；FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

官方来源

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