Airworks雾化器pe1200m
K号: K162041 · 2017-05-02
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决定日期2017-05-02
产品代码CAF
咨询委员会AN
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决定实质等同
器械摘要
Airworks Nebulizer pe1200m is the device name listed in this FDA 510(k) record. The listed applicant is Convexity Scientific, LLC. It received FDA 510(k) clearance on 2017-05-02 under 510(k) number K162041. 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 Airworks Nebulizer pe1200m?
Airworks Nebulizer pe1200m is a medical device that received FDA 510(k) clearance on 2017-05-02. The listed applicant is Convexity Scientific, LLC. The 510(k) number is K162041.
When did Airworks Nebulizer pe1200m receive FDA 510(k) clearance?
Airworks Nebulizer pe1200m received FDA 510(k) clearance on 2017-05-02, under 510(k) number K162041.
Who is the listed applicant for Airworks Nebulizer pe1200m?
The FDA 510(k) record lists Convexity Scientific, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Airworks Nebulizer pe1200m?
The FDA product code for Airworks Nebulizer pe1200m is CAF.
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：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
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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