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FDA 510(k)

ZyMot ICSI 精子分离装置，ZyMot 多精子分离装置（850µl，3ml）

K号: K173075 · 2018-03-08

申请人Dxnow, Inc.
决定日期2018-03-08
产品代码MQK
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决定实质等同

器械摘要

ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) is the device name listed in this FDA 510(k) record. The listed applicant is Dxnow, Inc.. It received FDA 510(k) clearance on 2018-03-08 under 510(k) number K173075. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)?

ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) is a medical device that received FDA 510(k) clearance on 2018-03-08. The listed applicant is Dxnow, Inc.. The 510(k) number is K173075.

When did ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) receive FDA 510(k) clearance?

ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) received FDA 510(k) clearance on 2018-03-08, under 510(k) number K173075.

Who is the listed applicant for ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)?

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

What is the FDA product code for ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)?

The FDA product code for ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) is MQK.

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：MQK）

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。

K241626SperSort™ 精子分离芯片（IPG02）Ipreg IncorporationK241454Minvitro® 玻璃化吸管 (MVT-VSN 系列，包括 MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)Guangzhou Hehong Biotech Co., Ltd.K241348SwimCount® 收割器（1 mL）；SwimCount® 收割器（3 mL）Motilitycount ApsK241341cryo-GO 冷冻玻璃化设备Fujifilm Irvine ScientificK240002G-Vitri™玻璃化吸管Gimbo Medical Technology Shenzhen Co., Ltd.K232980SpermAlign 精子分离装置Cytoswim, Ltd.

官方来源

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