UniPulse
K号: K182905 · 2018-12-14
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决定日期2018-12-14
产品代码DRL
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
UniPulse is the device name listed in this FDA 510(k) record. The listed applicant is Seaward Group. It received FDA 510(k) clearance on 2018-12-14 under 510(k) number K182905. The device is classified under product code DRL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the UniPulse?
UniPulse is a medical device that received FDA 510(k) clearance on 2018-12-14. The listed applicant is Seaward Group. The 510(k) number is K182905.
When did UniPulse receive FDA 510(k) clearance?
UniPulse received FDA 510(k) clearance on 2018-12-14, under 510(k) number K182905.
Who is the listed applicant for UniPulse?
The FDA 510(k) record lists Seaward Group as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UniPulse?
The FDA product code for UniPulse is DRL.
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。
相关器械（代码：DRL）
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。
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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