Anivia SG1000 Pump Console
K号: K230698 · 2023-04-18
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申请人Apmtd, Inc.
决定日期2023-04-18
产品代码DWA
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]
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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
Anivia SG1000 Pump Console is the device name listed in this FDA 510(k) record. The listed applicant is Apmtd, Inc.. It received FDA 510(k) clearance on 2023-04-18 under 510(k) number K230698. The device is classified under product code DWA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Anivia SG1000 Pump Console?
Anivia SG1000 Pump Console is a medical device that received FDA 510(k) clearance on 2023-04-18. The listed applicant is Apmtd, Inc.. The 510(k) number is K230698.
When did Anivia SG1000 Pump Console receive FDA 510(k) clearance?
Anivia SG1000 Pump Console received FDA 510(k) clearance on 2023-04-18, under 510(k) number K230698.
Who is the listed applicant for Anivia SG1000 Pump Console?
The FDA 510(k) record lists Apmtd, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Anivia SG1000 Pump Console?
The FDA product code for Anivia SG1000 Pump Console is DWA.
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Apmtd, Inc.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：DWA）
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。
K232788INSPIRA ART100Inspira Technologies Oxy B.H.N. , Ltd.K221491Anivia SG1000 Pump ConsoleApmtd, Inc.K192838Quantumn 中心血泵驱动-高压, Quantumn 中心血泵驱动-中压Spectrum Medical , Ltd.K200306CentriMag循环支持系统，CentriMag回（动脉）导管套装，CentriMag引流（静脉）导管套装Abbott (Formerly Thoratec Corporation)K191557CentriMag急性循环支持系统Thoratec Corporation (Now Part of Abbott)
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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