FDA 510(k)

PrisMax System Version 2

K号: K190910 · 2019-07-25

决定日期2019-07-25

产品代码KDI

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决定实质等同

器械摘要

PrisMax System Version 2 is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 2019-07-25 under 510(k) number K190910. 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 PrisMax System Version 2?

PrisMax System Version 2 is a medical device that received FDA 510(k) clearance on 2019-07-25. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K190910.

When did PrisMax System Version 2 receive FDA 510(k) clearance?

PrisMax System Version 2 received FDA 510(k) clearance on 2019-07-25, under 510(k) number K190910.

Who is the listed applicant for PrisMax System Version 2?

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

What is the FDA product code for PrisMax System Version 2?

The FDA product code for PrisMax System Version 2 is KDI.

列明Baxter Healthcare Corp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。

K163530PrisMax Control Unit

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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