FLIX-EMS
K号: K181419 · 2019-05-14
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决定日期2019-05-14
产品代码NGX
咨询委员会PM
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决定实质等同
器械摘要
FLIX-EMS is the device name listed in this FDA 510(k) record. The listed applicant is Casgarum Investment, S.L.. It received FDA 510(k) clearance on 2019-05-14 under 510(k) number K181419. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the FLIX-EMS?
FLIX-EMS is a medical device that received FDA 510(k) clearance on 2019-05-14. The listed applicant is Casgarum Investment, S.L.. The 510(k) number is K181419.
When did FLIX-EMS receive FDA 510(k) clearance?
FLIX-EMS received FDA 510(k) clearance on 2019-05-14, under 510(k) number K181419.
Who is the listed applicant for FLIX-EMS?
The FDA 510(k) record lists Casgarum Investment, S.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FLIX-EMS?
The FDA product code for FLIX-EMS is NGX.
相关器械（代码：NGX）
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官方来源
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