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FDA 510(k)

SPECTRA一次性单腔超声注射麻醉传导针

K号: K151069 · 2016-02-05

决定日期2016-02-05
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

SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle is the device name listed in this FDA 510(k) record. The listed applicant is Spectra Medical Devices, Inc.. It received FDA 510(k) clearance on 2016-02-05 under 510(k) number K151069. 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 SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle?

SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle is a medical device that received FDA 510(k) clearance on 2016-02-05. The listed applicant is Spectra Medical Devices, Inc.. The 510(k) number is K151069.

When did SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle receive FDA 510(k) clearance?

SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle received FDA 510(k) clearance on 2016-02-05, under 510(k) number K151069.

Who is the listed applicant for SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle?

The FDA 510(k) record lists Spectra Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle?

The FDA product code for SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle is BSP.

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相关器械(代码:BSP)

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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