FDA 510(k)

ON-Q* Pump with Bolus

K号: K181360 · 2019-03-22

决定日期2019-03-22

产品代码MEB

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

ON-Q* Pump with Bolus is the device name listed in this FDA 510(k) record. The listed applicant is Halyard Health. It received FDA 510(k) clearance on 2019-03-22 under 510(k) number K181360. The device is classified under product code MEB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ON-Q* Pump with Bolus?

ON-Q* Pump with Bolus is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Halyard Health. The 510(k) number is K181360.

When did ON-Q* Pump with Bolus receive FDA 510(k) clearance?

ON-Q* Pump with Bolus received FDA 510(k) clearance on 2019-03-22, under 510(k) number K181360.

Who is the listed applicant for ON-Q* Pump with Bolus?

The FDA 510(k) record lists Halyard Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ON-Q* Pump with Bolus?

The FDA product code for ON-Q* Pump with Bolus is MEB.

列明Halyard Health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。

K180646Halyard 紫罗兰色乳胶无粉检查手套，经化疗药物测试 K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit K160709HALYARD* PURPLE NITRILE – XTRA* 无粉检查手套 K153708Halyard 黑橙色无粉乳胶检查手套

官方来源

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