FDA 510(k)

儿科脊柱侧弯手术中的输血风险因素和血液回收器的影响

K号: K181743 · 2019-07-30

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 Transfer Accessory (BTA) 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 K181743. 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 Transfer Accessory (BTA)?

Blood Transfer Accessory (BTA) 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 K181743.

When did Blood Transfer Accessory (BTA) receive FDA 510(k) clearance?

Blood Transfer Accessory (BTA) received FDA 510(k) clearance on 2019-07-30, under 510(k) number K181743.

Who is the listed applicant for Blood Transfer Accessory (BTA)?

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 Transfer Accessory (BTA)?

The FDA product code for Blood Transfer Accessory (BTA) is JKA.

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。

K221783SafetiCET 安全注射针 K221604SafetiHeel, MediHeel, Novaplus K193074Bevel Up Holder K181754血液采集附件（BUCA）

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

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