OneTouch Via 需求胰岛素输送系统
K号: K163357 · 2017-06-07
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决定日期2017-06-07
产品代码OPP
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
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器械摘要
OneTouch Via On-Demand Insulin Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Lifescan Europe, A Division of Cilag GmbH. It received FDA 510(k) clearance on 2017-06-07 under 510(k) number K163357. The device is classified under product code OPP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OneTouch Via On-Demand Insulin Delivery System?
OneTouch Via On-Demand Insulin Delivery System is a medical device that received FDA 510(k) clearance on 2017-06-07. The listed applicant is Lifescan Europe, A Division of Cilag GmbH. The 510(k) number is K163357.
When did OneTouch Via On-Demand Insulin Delivery System receive FDA 510(k) clearance?
OneTouch Via On-Demand Insulin Delivery System received FDA 510(k) clearance on 2017-06-07, under 510(k) number K163357.
Who is the listed applicant for OneTouch Via On-Demand Insulin Delivery System?
The FDA 510(k) record lists Lifescan Europe, A Division of Cilag GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OneTouch Via On-Demand Insulin Delivery System?
The FDA product code for OneTouch Via On-Demand Insulin Delivery System is OPP.
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相关器械（代码：OPP）
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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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