EasyPoint 血液采集套装
K号: K202325 · 2021-04-09
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决定日期2021-04-09
产品代码JKA
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
EasyPoint Blood Collection Plus is the device name listed in this FDA 510(k) record. The listed applicant is Retractable Technologies, Inc.. It received FDA 510(k) clearance on 2021-04-09 under 510(k) number K202325. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EasyPoint Blood Collection Plus?
EasyPoint Blood Collection Plus is a medical device that received FDA 510(k) clearance on 2021-04-09. The listed applicant is Retractable Technologies, Inc.. The 510(k) number is K202325.
When did EasyPoint Blood Collection Plus receive FDA 510(k) clearance?
EasyPoint Blood Collection Plus received FDA 510(k) clearance on 2021-04-09, under 510(k) number K202325.
Who is the listed applicant for EasyPoint Blood Collection Plus?
The FDA 510(k) record lists Retractable Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EasyPoint Blood Collection Plus?
The FDA product code for EasyPoint Blood Collection Plus is JKA.
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：JKA）
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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