Guarded Luer Connector
K号: K173577 · 2018-06-07
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决定日期2018-06-07
产品代码LHI
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
Guarded Luer Connector is the device name listed in this FDA 510(k) record. The listed applicant is International Medical Industries, Inc.. It received FDA 510(k) clearance on 2018-06-07 under 510(k) number K173577. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Guarded Luer Connector?
Guarded Luer Connector is a medical device that received FDA 510(k) clearance on 2018-06-07. The listed applicant is International Medical Industries, Inc.. The 510(k) number is K173577.
When did Guarded Luer Connector receive FDA 510(k) clearance?
Guarded Luer Connector received FDA 510(k) clearance on 2018-06-07, under 510(k) number K173577.
Who is the listed applicant for Guarded Luer Connector?
The FDA 510(k) record lists International Medical Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Guarded Luer Connector?
The FDA product code for Guarded Luer Connector is LHI.
相关临床试验
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。
列明International Medical Industries, 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：LHI）
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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