OC-Auto SENSOR io iFOB 测试
K号: K191147 · 2020-01-02
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决定日期2020-01-02
产品代码OOX
咨询委员会HE
请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。
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器械摘要
OC-Auto SENSOR io iFOB Test is the device name listed in this FDA 510(k) record. The listed applicant is Eiken Chemical Co., Ltd.. It received FDA 510(k) clearance on 2020-01-02 under 510(k) number K191147. The device is classified under product code OOX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OC-Auto SENSOR io iFOB Test?
OC-Auto SENSOR io iFOB Test is a medical device that received FDA 510(k) clearance on 2020-01-02. The listed applicant is Eiken Chemical Co., Ltd.. The 510(k) number is K191147.
When did OC-Auto SENSOR io iFOB Test receive FDA 510(k) clearance?
OC-Auto SENSOR io iFOB Test received FDA 510(k) clearance on 2020-01-02, under 510(k) number K191147.
Who is the listed applicant for OC-Auto SENSOR io iFOB Test?
The FDA 510(k) record lists Eiken Chemical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OC-Auto SENSOR io iFOB Test?
The FDA product code for OC-Auto SENSOR io iFOB Test is OOX.
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相关器械（代码：OOX）
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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