ProntoPump 消毒管路套装
K号: K200893 · 2021-05-04
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申请人Ipax, Inc.
决定日期2021-05-04
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
ProntoPump Sterile Tube Set is the device name listed in this FDA 510(k) record. The listed applicant is Ipax, Inc.. It received FDA 510(k) clearance on 2021-05-04 under 510(k) number K200893. 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 ProntoPump Sterile Tube Set?
ProntoPump Sterile Tube Set is a medical device that received FDA 510(k) clearance on 2021-05-04. The listed applicant is Ipax, Inc.. The 510(k) number is K200893.
When did ProntoPump Sterile Tube Set receive FDA 510(k) clearance?
ProntoPump Sterile Tube Set received FDA 510(k) clearance on 2021-05-04, under 510(k) number K200893.
Who is the listed applicant for ProntoPump Sterile Tube Set?
The FDA 510(k) record lists Ipax, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ProntoPump Sterile Tube Set?
The FDA product code for ProntoPump Sterile Tube Set 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。
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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