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FDA 510(k)

Pasteur 吸管 3mL,Pasteur 吸管 1mL

K号: K201213 · 2020-12-16

申请人Hertart Aps
决定日期2020-12-16
产品代码MQK
咨询委员会OB 请注意,由于您没有提供具体的医疗设备监管文本,我无法进行翻译。请提供具体的文本内容,以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

Pasteur Pipette 3mL, Pasteur Pipette 1mL is the device name listed in this FDA 510(k) record. The listed applicant is Hertart Aps. It received FDA 510(k) clearance on 2020-12-16 under 510(k) number K201213. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Pasteur Pipette 3mL, Pasteur Pipette 1mL?

Pasteur Pipette 3mL, Pasteur Pipette 1mL is a medical device that received FDA 510(k) clearance on 2020-12-16. The listed applicant is Hertart Aps. The 510(k) number is K201213.

When did Pasteur Pipette 3mL, Pasteur Pipette 1mL receive FDA 510(k) clearance?

Pasteur Pipette 3mL, Pasteur Pipette 1mL received FDA 510(k) clearance on 2020-12-16, under 510(k) number K201213.

Who is the listed applicant for Pasteur Pipette 3mL, Pasteur Pipette 1mL?

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

What is the FDA product code for Pasteur Pipette 3mL, Pasteur Pipette 1mL?

The FDA product code for Pasteur Pipette 3mL, Pasteur Pipette 1mL is MQK.

相关临床试验

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。

相关器械(代码:MQK)

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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