CardioLogs 心电图分析平台
K号: K170568 · 2017-06-26
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决定日期2017-06-26
产品代码DPS
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
CardioLogs ECG Analysis Platform is the device name listed in this FDA 510(k) record. The listed applicant is Cardiologs Technologies. It received FDA 510(k) clearance on 2017-06-26 under 510(k) number K170568. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CardioLogs ECG Analysis Platform?
CardioLogs ECG Analysis Platform is a medical device that received FDA 510(k) clearance on 2017-06-26. The listed applicant is Cardiologs Technologies. The 510(k) number is K170568.
When did CardioLogs ECG Analysis Platform receive FDA 510(k) clearance?
CardioLogs ECG Analysis Platform received FDA 510(k) clearance on 2017-06-26, under 510(k) number K170568.
Who is the listed applicant for CardioLogs ECG Analysis Platform?
The FDA 510(k) record lists Cardiologs Technologies as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CardioLogs ECG Analysis Platform?
The FDA product code for CardioLogs ECG Analysis Platform is DPS.
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Cardiologs Technologies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：DPS）
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。
K254255S-Patch 心脏AIWellysis Corp.K252463SE-1202系列心电图机（型号：SE-1202，SE-1202E）Edan Instruments, Inc.K251670MAC 7 静息心电图分析系统Ge Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO（SCT02）WithingsK250569Cardiologs Holter PlatformPhilips France Commercial
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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