CURA 778
K号: K192590 · 2020-03-05
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器械摘要
CURA 778 is the device name listed in this FDA 510(k) record. The listed applicant is Fmi Medical Systems, Inc.. It received FDA 510(k) clearance on 2020-03-05 under 510(k) number K192590. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CURA 778?
CURA 778 is a medical device that received FDA 510(k) clearance on 2020-03-05. The listed applicant is Fmi Medical Systems, Inc.. The 510(k) number is K192590.
When did CURA 778 receive FDA 510(k) clearance?
CURA 778 received FDA 510(k) clearance on 2020-03-05, under 510(k) number K192590.
Who is the listed applicant for CURA 778?
The FDA 510(k) record lists Fmi Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CURA 778?
The FDA product code for CURA 778 is JAK.
列明Fmi Medical Systems, Inc.为申报人的其他记录
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：JAK）
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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