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FDA 510(k)

Quantum Smart Occluder LH (左手), Quantum Smart Occluder LH (右手)

K号: K190282 · 2019-05-24

申请人Spectrum Medical , Ltd.
决定日期2019-05-24
产品代码DTQ
咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同

器械摘要

Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2019-05-24 under 510(k) number K190282. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)?

Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) is a medical device that received FDA 510(k) clearance on 2019-05-24. The listed applicant is Spectrum Medical , Ltd.. The 510(k) number is K190282.

When did Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) receive FDA 510(k) clearance?

Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) received FDA 510(k) clearance on 2019-05-24, under 510(k) number K190282.

Who is the listed applicant for Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)?

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

What is the FDA product code for Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)?

The FDA product code for Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) is DTQ.

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Spectrum Medical , Ltd.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。

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相关器械（代码：DTQ）

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。

K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbHK221895Terumo 先进灌注系统 1Terumo Cardiovascular Systems CorporationK221373Essenz HLMLivanova Deutschland, GmbHK210130Stockert S5 SystemLivanova Deutschland, GmbHK202125Century灌注系统Century Hlm, LLCK173834Quantum 泵控制台Spectrum Medical , Ltd.

官方来源

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