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FDA 510(k)

Bicarby 透析液 RFP-402 (RFP-402-G)；Bicarby 透析液 RFP-400 (RFP-400-G)；Bicarby 透析液 RFP-407 (RFP-407-G)；Bicarby 透析液 RFP-401 (RFP-401-G)；Bicarby 透析液 RFP-404 (RFP-404-G)；Bicarby 透析液 RFP-456 (RFP-456-G)；Ci-Ca 透析液 2K (RFP-457-G)；Ci-Ca 透析液 4K (RFP-458-G)

K号: K243786 · 2025-04-04

申请人Fresenius Medical Care Renal Therapies Group, LLC
决定日期2025-04-04
产品代码KPO
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

Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) 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 2025-04-04 under 510(k) number K243786. 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 Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)?

Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K243786.

When did Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) receive FDA 510(k) clearance?

Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) received FDA 510(k) clearance on 2025-04-04, under 510(k) number K243786.

Who is the listed applicant for Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)?

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 Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)?

The FDA product code for Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) is KPO.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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 V500K252377NxStage System One with NxViewK252459multiFlux 130（F00013123）；multiFlux 160（F00013124）K253462NaturaLyte® 干碳酸氢钠浓缩液（08-4112-2）K253518FX CorAL 40；FX CorAL 50K250634BCM2-身体成分监测仪

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。

K260799尼普洛干酸浓缩液混合器Nipro Technical Solutions, IncoporatedK253462NaturaLyte® 干碳酸氢钠浓缩液（08-4112-2）Fresenius Medical Care Renal Therapies Group, LLCK252180Bicarby 透析液 RFP-404 (RFP-404-W)；Bicarby 透析液 RFP-403 (RFP-403-W)；Bicarby 透析液 RFP-403 (RFP-403-G)；Bicarby 透析液 RFP-453 (RFP-453-W)；Bicarby 透析液 RFP-453 (RFP-453-G)；Bicarby 透析液 RFP-454 (RFP-454-W)；Bicarby 透析液 RFP-454 (RFP-454-G)；Bicarby 透析液 RFP-456 (RFP-456-W)Fresenius Medical Care Renal Therapies Group, LLCK240920HemoCare 碳酸氢钠浓缩液套装（BCS）Deka Research and DevelopmentK233950pureFLOW 402（F00012067）；pureFLOW 406（F00012068）；pureFLOW 401（F00012069）；pureFLOW 400（F00012070）Fresenius Medical Care Renal Therapies Group, LLCK233213NxStage PureFlow SolutionNxstage Medical, Inc.

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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