FDA 510(k)

Arrow 硬膜外针 KZ-05500-007(Luer)；KZ-05500-009 (NRFit)

K号: K190026 · 2019-08-21

决定日期2019-08-21

产品代码BSP

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2019-08-21 under 510(k) number K190026. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)?

Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) is a medical device that received FDA 510(k) clearance on 2019-08-21. The listed applicant is Teleflex Medical. The 510(k) number is K190026.

When did Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) receive FDA 510(k) clearance?

Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) received FDA 510(k) clearance on 2019-08-21, under 510(k) number K190026.

Who is the listed applicant for Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)?

FDA 510(k)记录显示Teleflex Medical为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)?

The FDA product code for Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) is BSP.

列明Teleflex Medical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。

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官方来源

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