Assert-IQ (DM5100)
K号: K253516 · 2025-12-18
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决定日期2025-12-18
产品代码MXD
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
Assert-IQ (DM5100) is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2025-12-18 under 510(k) number K253516. The device is classified under product code MXD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Assert-IQ (DM5100)?
Assert-IQ (DM5100) is a medical device that received FDA 510(k) clearance on 2025-12-18. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K253516.
When did Assert-IQ (DM5100) receive FDA 510(k) clearance?
Assert-IQ (DM5100) received FDA 510(k) clearance on 2025-12-18, under 510(k) number K253516.
Who is the listed applicant for Assert-IQ (DM5100)?
The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Assert-IQ (DM5100)?
The FDA product code for Assert-IQ (DM5100) is MXD.
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ABBOTT MEDICAL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：MXD）
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。
K262735LINQ II 可植入式心脏监测器（ICM）（LNQ22）Medtronic, Inc.K261074BIOMONITOR IV（471155）Biotronik, Inc.K251221Assert-IQ (DM5000)；Assert-IQ (DM5300)；Assert-IQ (DM5500)；Merlin.net (MN7000)AbbottK252593LUX-Dx II 可植入式心脏监测器 (M302); LUX-Dx II+ 可植入式心脏监测器 (M312)Boston Scientific CorporationK240693LINQ II®植入式心脏监测器（ICM）Medtronic, Inc.K233562LINQ II 可植入式心脏监测器Medtronic, Inc.
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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