型号9100肺功能/呼吸流量计
K号: K221030 · 2022-07-15
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决定日期2022-07-15
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
Model 9100 PFT/DICO is the device name listed in this FDA 510(k) record. The listed applicant is Vitalograph Ireland, Ltd.. It received FDA 510(k) clearance on 2022-07-15 under 510(k) number K221030. 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 Model 9100 PFT/DICO?
Model 9100 PFT/DICO is a medical device that received FDA 510(k) clearance on 2022-07-15. The listed applicant is Vitalograph Ireland, Ltd.. The 510(k) number is K221030.
When did Model 9100 PFT/DICO receive FDA 510(k) clearance?
Model 9100 PFT/DICO received FDA 510(k) clearance on 2022-07-15, under 510(k) number K221030.
Who is the listed applicant for Model 9100 PFT/DICO?
The FDA 510(k) record lists Vitalograph Ireland, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Model 9100 PFT/DICO?
The FDA product code for Model 9100 PFT/DICO 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Vitalograph Ireland, Ltd.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 CorporationK223629SpiroSphere, SpiroSphereECG, CardioSphereEresearchtechnology GmbHK231561肺功能检测仪，型号：A9Guangzhou Homesun Medical Technology Co., Ltd.K222982Virtus 代谢监测仪Virtus Technology ApsK202754MasterScope，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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