血液采集附件（BUCA）
K号: K181754 · 2019-07-30
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决定日期2019-07-30
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
Blood Collection Accessory (BUCA) is the device name listed in this FDA 510(k) record. The listed applicant is Nsp Tech Pte, Ltd.. It received FDA 510(k) clearance on 2019-07-30 under 510(k) number K181754. 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 Blood Collection Accessory (BUCA)?
Blood Collection Accessory (BUCA) is a medical device that received FDA 510(k) clearance on 2019-07-30. The listed applicant is Nsp Tech Pte, Ltd.. The 510(k) number is K181754.
When did Blood Collection Accessory (BUCA) receive FDA 510(k) clearance?
Blood Collection Accessory (BUCA) received FDA 510(k) clearance on 2019-07-30, under 510(k) number K181754.
Who is the listed applicant for Blood Collection Accessory (BUCA)?
The FDA 510(k) record lists Nsp Tech Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Blood Collection Accessory (BUCA)?
The FDA product code for Blood Collection Accessory (BUCA) 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。
列明Nsp Tech Pte, Ltd.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：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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