FDA 510(k)

BD 注射器 NRFit Lok 和 BD 注射器 NRFit Slip

K号: K192538 · 2020-09-04

决定日期2020-09-04

产品代码QEH

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

BD Syringe NRFit Lok and BD Syringe NRFit Slip is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2020-09-04 under 510(k) number K192538. The device is classified under product code QEH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BD Syringe NRFit Lok and BD Syringe NRFit Slip?

BD Syringe NRFit Lok and BD Syringe NRFit Slip is a medical device that received FDA 510(k) clearance on 2020-09-04. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K192538.

When did BD Syringe NRFit Lok and BD Syringe NRFit Slip receive FDA 510(k) clearance?

BD Syringe NRFit Lok and BD Syringe NRFit Slip received FDA 510(k) clearance on 2020-09-04, under 510(k) number K192538.

Who is the listed applicant for BD Syringe NRFit Lok and BD Syringe NRFit Slip?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Syringe NRFit Lok and BD Syringe NRFit Slip?

The FDA product code for BD Syringe NRFit Lok and BD Syringe NRFit Slip is QEH.

列明Becton, Dickinson and Company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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