SpiroSphere, SpiroSphereECG, CardioSphere
K号: K223629 · 2024-05-28
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决定日期2024-05-28
产品代码BTY
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
SpiroSphere, SpiroSphereECG, CardioSphere is the device name listed in this FDA 510(k) record. The listed applicant is Eresearchtechnology GmbH. It received FDA 510(k) clearance on 2024-05-28 under 510(k) number K223629. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SpiroSphere, SpiroSphereECG, CardioSphere?
SpiroSphere, SpiroSphereECG, CardioSphere is a medical device that received FDA 510(k) clearance on 2024-05-28. The listed applicant is Eresearchtechnology GmbH. The 510(k) number is K223629.
When did SpiroSphere, SpiroSphereECG, CardioSphere receive FDA 510(k) clearance?
SpiroSphere, SpiroSphereECG, CardioSphere received FDA 510(k) clearance on 2024-05-28, under 510(k) number K223629.
Who is the listed applicant for SpiroSphere, SpiroSphereECG, CardioSphere?
The FDA 510(k) record lists Eresearchtechnology GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SpiroSphere, SpiroSphereECG, CardioSphere?
The FDA product code for SpiroSphere, SpiroSphereECG, CardioSphere is BTY.
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Eresearchtechnology GmbH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：BTY）
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。
K260242CPETWise 平台Medibyt , Ltd.K242809Ascent 心肺诊断软件Medical Graphics CorporationK231561肺功能检测仪，型号：A9Guangzhou Homesun Medical Technology Co., Ltd.K222982Virtus 代谢监测仪Virtus Technology ApsK221030型号9100肺功能/呼吸流量计Vitalograph Ireland, Ltd.K202754MasterScope，MasterScope CT，MasterScope ECG，MasterScope WSSUEresearchtechnology GmbH
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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