HD+12, HD+15
K号: K220526 · 2023-05-15
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决定日期2023-05-15
产品代码DRG
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
HD+12, HD+15 is the device name listed in this FDA 510(k) record. The listed applicant is Cardioline S.P.A. It received FDA 510(k) clearance on 2023-05-15 under 510(k) number K220526. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the HD+12, HD+15?
HD+12, HD+15 is a medical device that received FDA 510(k) clearance on 2023-05-15. The listed applicant is Cardioline S.P.A. The 510(k) number is K220526.
When did HD+12, HD+15 receive FDA 510(k) clearance?
HD+12, HD+15 received FDA 510(k) clearance on 2023-05-15, under 510(k) number K220526.
Who is the listed applicant for HD+12, HD+15?
The FDA 510(k) record lists Cardioline S.P.A as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HD+12, HD+15?
The FDA product code for HD+12, HD+15 is DRG.
列明Cardioline S.P.A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：DRG）
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。
K261569UbiqVue™ 2AYe 心脏系统（UX2253）Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos 心肺康复The ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A 多参数系统（UX2550）Lifesignals, 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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