MouthLab生命体征监测系统
K号: K201635 · 2021-02-06
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决定日期2021-02-06
产品代码MWI
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]
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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
MouthLab Vital Signs Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Multisensor Diagnostics (Dba Aidar Health). It received FDA 510(k) clearance on 2021-02-06 under 510(k) number K201635. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the MouthLab Vital Signs Monitoring System?
MouthLab Vital Signs Monitoring System is a medical device that received FDA 510(k) clearance on 2021-02-06. The listed applicant is Multisensor Diagnostics (Dba Aidar Health). The 510(k) number is K201635.
When did MouthLab Vital Signs Monitoring System receive FDA 510(k) clearance?
MouthLab Vital Signs Monitoring System received FDA 510(k) clearance on 2021-02-06, under 510(k) number K201635.
Who is the listed applicant for MouthLab Vital Signs Monitoring System?
The FDA 510(k) record lists Multisensor Diagnostics (Dba Aidar Health) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MouthLab Vital Signs Monitoring System?
The FDA product code for MouthLab Vital Signs Monitoring System is MWI.
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：MWI）
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。
K260438生命体征监测仪（CLEO2）Infinium Medical, Inc.K253417Masimo 根部监测系统Masimo CorporationK253196Midmark 800 数字生命体征设备（1-300-0100，1-300-0200，1-300-0300，1-300-0400）Midmark CorporationK253436c-med0 阿尔法Cosinuss GmbHK250135WAVE 临床平台（2.0.000）Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV
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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