FDA 510(k)

Solo-Dex Fascile 连续外周神经阻滞导管和针套装

K号: K151072 · 2016-01-22

决定日期2016-01-22

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

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is the device name listed in this FDA 510(k) record. The listed applicant is Solo-Dex, Inc.. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K151072. 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 Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit?

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Solo-Dex, Inc.. The 510(k) number is K151072.

When did Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit receive FDA 510(k) clearance?

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit received FDA 510(k) clearance on 2016-01-22, under 510(k) number K151072.

Who is the listed applicant for Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit?

The FDA 510(k) record lists Solo-Dex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit?

The FDA product code for Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is BSP.

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Solo-Dex Fascile 连续外周神经阻滞导管和针套装

器械摘要

常见问题

相关临床试验

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官方来源