Assert-IQ® 可植入式心脏监测仪
K号: K230286 · 2023-05-17
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决定日期2023-05-17
产品代码MXC
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
Assert-IQ™ Insertable Cardiac Monitor is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2023-05-17 under 510(k) number K230286. The device is classified under product code MXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Assert-IQ™ Insertable Cardiac Monitor?
Assert-IQ™ Insertable Cardiac Monitor is a medical device that received FDA 510(k) clearance on 2023-05-17. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K230286.
When did Assert-IQ™ Insertable Cardiac Monitor receive FDA 510(k) clearance?
Assert-IQ™ Insertable Cardiac Monitor received FDA 510(k) clearance on 2023-05-17, under 510(k) number K230286.
Who is the listed applicant for Assert-IQ™ Insertable Cardiac Monitor?
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™ Insertable Cardiac Monitor?
The FDA product code for Assert-IQ™ Insertable Cardiac Monitor is MXC.
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：MXC）
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。
K212206Jot Dx 可植入式心脏监测器Abbott (St. Jude Medical)K202876Confirm Rx 可植入式心脏监测器Abbott (St. Jude Medical)K202888Confirm Rx 可植入式心脏监测器Abbott (St. Jude Medical)K193310我的梅林移动应用（Android），我的梅林移动应用（iOS）Abbott (St. Jude Medical)K192593Confirm Rx 可植入式心脏监测器AbbottK190295Confirm Rx 可植入式心脏监测器Abbott (St. Jude Medical)
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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