Quantum 工作站 12.1
K号: K181923 · 2018-08-17
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决定日期2018-08-17
产品代码DRY
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：
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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 Workstation 12.1 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 2018-08-17 under 510(k) number K181923. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Quantum Workstation 12.1?
Quantum Workstation 12.1 is a medical device that received FDA 510(k) clearance on 2018-08-17. The listed applicant is Spectrum Medical , Ltd.. The 510(k) number is K181923.
When did Quantum Workstation 12.1 receive FDA 510(k) clearance?
Quantum Workstation 12.1 received FDA 510(k) clearance on 2018-08-17, under 510(k) number K181923.
Who is the listed applicant for Quantum Workstation 12.1?
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 Workstation 12.1?
The FDA product code for Quantum Workstation 12.1 is DRY.
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。
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。
相关器械（代码：DRY）
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。
K234065CDI OneView 监控系统Terumo Cardiovascular Systems CorporationK202154B-CaptaLivanova Deutschland, GmbHK202557Quantum 工作站 12 EliteSpectrum Medical , Ltd.K182110CDI 血液参数监测系统 550Terumo Cardiovascular Systems CorporationK173591Quantum 诊断模块, Quantum 诊断模块 - 无气体Spectrum Medical , Ltd.K163657Quantum 工作站Spectrum Medical , Ltd.
官方来源
在 FDA 数据库中查看 →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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