FDA 510(k)

Tablo® 血液透析系统；TabloCart™ 带预过滤抽屉

K号: K232776 · 2024-05-03

决定日期2024-05-03

产品代码KDI

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决定实质等同

器械摘要

Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer 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 2024-05-03 under 510(k) number K232776. 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® Hemodialysis System; TabloCart™ with Prefiltration Drawer?

Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer is a medical device that received FDA 510(k) clearance on 2024-05-03. The listed applicant is Outset Medical, Inc.. The 510(k) number is K232776.

When did Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer receive FDA 510(k) clearance?

Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer received FDA 510(k) clearance on 2024-05-03, under 510(k) number K232776.

Who is the listed applicant for Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer?

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® Hemodialysis System; TabloCart™ with Prefiltration Drawer?

The FDA product code for Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer 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）K233335Tablo® 血液透析系统 K223248Tablo® 血液透析系统 K211370Tablo血液透析系统 K210782Tablo药盒 K200741Tablo血液透析系统

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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