Carnation 便携式监测仪
K号: K191471 · 2019-08-30
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决定日期2019-08-30
产品代码DSH
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
Carnation Ambulatory Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Bardy Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-08-30 under 510(k) number K191471. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Carnation Ambulatory Monitor?
Carnation Ambulatory Monitor is a medical device that received FDA 510(k) clearance on 2019-08-30. The listed applicant is Bardy Diagnostics, Inc.. The 510(k) number is K191471.
When did Carnation Ambulatory Monitor receive FDA 510(k) clearance?
Carnation Ambulatory Monitor received FDA 510(k) clearance on 2019-08-30, under 510(k) number K191471.
Who is the listed applicant for Carnation Ambulatory Monitor?
The FDA 510(k) record lists Bardy Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Carnation Ambulatory Monitor?
The FDA product code for Carnation Ambulatory Monitor is DSH.
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Bardy Diagnostics, Inc.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：DSH）
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。
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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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