ROSC-U Mini 胸部压缩器 (RMCC)
K号: K153628 · 2016-01-30
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决定日期2016-01-30
产品代码DRM
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
ROSC-U Mini Chest Compressor (RMCC) is the device name listed in this FDA 510(k) record. The listed applicant is Resuscitation International, LLC. It received FDA 510(k) clearance on 2016-01-30 under 510(k) number K153628. The device is classified under product code DRM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ROSC-U Mini Chest Compressor (RMCC)?
ROSC-U Mini Chest Compressor (RMCC) is a medical device that received FDA 510(k) clearance on 2016-01-30. The listed applicant is Resuscitation International, LLC. The 510(k) number is K153628.
When did ROSC-U Mini Chest Compressor (RMCC) receive FDA 510(k) clearance?
ROSC-U Mini Chest Compressor (RMCC) received FDA 510(k) clearance on 2016-01-30, under 510(k) number K153628.
Who is the listed applicant for ROSC-U Mini Chest Compressor (RMCC)?
The FDA 510(k) record lists Resuscitation International, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ROSC-U Mini Chest Compressor (RMCC)?
The FDA product code for ROSC-U Mini Chest Compressor (RMCC) is DRM.
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：DRM）
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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