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FDA 510(k)

Purema H Hemoconcentrator - Pediatric

K号: K243920 · 2025-09-19

申请人Medica USA, Inc.
决定日期2025-09-19
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

Purema H Hemoconcentrator - Pediatric is the device name listed in this FDA 510(k) record. The listed applicant is Medica USA, Inc.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K243920. 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 Purema H Hemoconcentrator - Pediatric?

Purema H Hemoconcentrator - Pediatric is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Medica USA, Inc.. The 510(k) number is K243920.

When did Purema H Hemoconcentrator - Pediatric receive FDA 510(k) clearance?

Purema H Hemoconcentrator - Pediatric received FDA 510(k) clearance on 2025-09-19, under 510(k) number K243920.

Who is the listed applicant for Purema H Hemoconcentrator - Pediatric?

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

What is the FDA product code for Purema H Hemoconcentrator - Pediatric?

The FDA product code for Purema H Hemoconcentrator - Pediatric is KDI.

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

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, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130（F00013123）；multiFlux 160（F00013124）Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo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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