MiCor A100可穿戴心电图记录仪
K号: K162665 · 2018-01-26
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决定日期2018-01-26
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
MiCor A100 Wearable ECG Recorder is the device name listed in this FDA 510(k) record. The listed applicant is Mitac International Corp.. It received FDA 510(k) clearance on 2018-01-26 under 510(k) number K162665. 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 MiCor A100 Wearable ECG Recorder?
MiCor A100 Wearable ECG Recorder is a medical device that received FDA 510(k) clearance on 2018-01-26. The listed applicant is Mitac International Corp.. The 510(k) number is K162665.
When did MiCor A100 Wearable ECG Recorder receive FDA 510(k) clearance?
MiCor A100 Wearable ECG Recorder received FDA 510(k) clearance on 2018-01-26, under 510(k) number K162665.
Who is the listed applicant for MiCor A100 Wearable ECG Recorder?
The FDA 510(k) record lists Mitac International Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MiCor A100 Wearable ECG Recorder?
The FDA product code for MiCor A100 Wearable ECG Recorder 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。
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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