iVue
K号: K163475 · 2017-06-09
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决定日期2017-06-09
产品代码OBO
咨询委员会OP
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决定实质等同
器械摘要
iVue is the device name listed in this FDA 510(k) record. The listed applicant is Optovue, Inc.. It received FDA 510(k) clearance on 2017-06-09 under 510(k) number K163475. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the iVue?
iVue is a medical device that received FDA 510(k) clearance on 2017-06-09. The listed applicant is Optovue, Inc.. The 510(k) number is K163475.
When did iVue receive FDA 510(k) clearance?
iVue received FDA 510(k) clearance on 2017-06-09, under 510(k) number K163475.
Who is the listed applicant for iVue?
The FDA 510(k) record lists Optovue, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iVue?
The FDA product code for iVue is OBO.
列明Optovue, 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：OBO）
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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