FDA 510(k)

NaturaLyte® 干碳酸氢钠浓缩液（08-4112-2）

K号: K253462 · 2026-01-29

申请人Fresenius Medical Care Renal Therapies Group, LLC

决定日期2026-01-29

产品代码KPO

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决定实质等同

器械摘要

NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2026-01-29 under 510(k) number K253462. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)?

NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) is a medical device that received FDA 510(k) clearance on 2026-01-29. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K253462.

When did NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) receive FDA 510(k) clearance?

NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) received FDA 510(k) clearance on 2026-01-29, under 510(k) number K253462.

Who is the listed applicant for NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)?

FDA 510(k)记录中列出Fresenius Medical Care Renal Therapies Group, LLC为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)?

The FDA product code for NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) is KPO.

列明Fresenius Medical Care Renal Therapies Group, LLC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。

K261267Careflux H60；Careflux H70；Careflux V500 K252377NxStage System One with NxView K252459multiFlux 130（F00013123）；multiFlux 160（F00013124）K253518FX CorAL 40；FX CorAL 50 K250634BCM2-身体成分监测仪 K250471AquaC UNO H

查看所有 48 个设备 →

相关器械（代码：KPO）

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。

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