InnoSpire Go
K号: K170853 · 2017-11-02
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决定日期2017-11-02
产品代码CAF
咨询委员会AN
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器械摘要
InnoSpire Go is the device name listed in this FDA 510(k) record. The listed applicant is Respironics Respiratory Drug Delivery (Uk) , Ltd.. It received FDA 510(k) clearance on 2017-11-02 under 510(k) number K170853. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the InnoSpire Go?
InnoSpire Go is a medical device that received FDA 510(k) clearance on 2017-11-02. The listed applicant is Respironics Respiratory Drug Delivery (Uk) , Ltd.. The 510(k) number is K170853.
When did InnoSpire Go receive FDA 510(k) clearance?
InnoSpire Go received FDA 510(k) clearance on 2017-11-02, under 510(k) number K170853.
Who is the listed applicant for InnoSpire Go?
The FDA 510(k) record lists Respironics Respiratory Drug Delivery (Uk) , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for InnoSpire Go?
The FDA product code for InnoSpire Go is CAF.
相关临床试验
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相关器械（代码：CAF）
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。
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官方来源
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