Essenz HLM, Essenz ILBM
K号: K232291 · 2023-08-24
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决定日期2023-08-24
产品代码DTQ
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
Essenz HLM, Essenz ILBM is the device name listed in this FDA 510(k) record. The listed applicant is Livanova Deutschland, GmbH. It received FDA 510(k) clearance on 2023-08-24 under 510(k) number K232291. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Essenz HLM, Essenz ILBM?
Essenz HLM, Essenz ILBM is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is Livanova Deutschland, GmbH. The 510(k) number is K232291.
When did Essenz HLM, Essenz ILBM receive FDA 510(k) clearance?
Essenz HLM, Essenz ILBM received FDA 510(k) clearance on 2023-08-24, under 510(k) number K232291.
Who is the listed applicant for Essenz HLM, Essenz ILBM?
The FDA 510(k) record lists Livanova Deutschland, GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Essenz HLM, Essenz ILBM?
The FDA product code for Essenz HLM, Essenz ILBM is DTQ.
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Livanova Deutschland, GmbH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：DTQ）
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。
K221895Terumo 先进灌注系统 1Terumo Cardiovascular Systems CorporationK221373Essenz HLMLivanova Deutschland, GmbHK210130Stockert S5 SystemLivanova Deutschland, GmbHK202125Century灌注系统Century Hlm, LLCK190282Quantum Smart Occluder LH (左手), Quantum Smart Occluder LH (右手)Spectrum Medical , Ltd.K173834Quantum 泵控制台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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