Saalio
K号: K191436 · 2019-10-18
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决定日期2019-10-18
产品代码EGJ
咨询委员会PM
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决定实质等同
器械摘要
Saalio is the device name listed in this FDA 510(k) record. The listed applicant is Saalmann Medical GmbH & Co. KG. It received FDA 510(k) clearance on 2019-10-18 under 510(k) number K191436. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Saalio?
Saalio is a medical device that received FDA 510(k) clearance on 2019-10-18. The listed applicant is Saalmann Medical GmbH & Co. KG. The 510(k) number is K191436.
When did Saalio receive FDA 510(k) clearance?
Saalio received FDA 510(k) clearance on 2019-10-18, under 510(k) number K191436.
Who is the listed applicant for Saalio?
The FDA 510(k) record lists Saalmann Medical GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Saalio?
The FDA product code for Saalio is EGJ.
相关临床试验
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相关器械（代码：EGJ）
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。
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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