FDA 510(k)

PAL一次性导管

K号: K192694 · 2020-05-14

决定日期2020-05-14

产品代码QPB

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决定实质等同

器械摘要

PAL Single-Use Cannulas is the device name listed in this FDA 510(k) record. The listed applicant is Microaire Surgical Instruments. It received FDA 510(k) clearance on 2020-05-14 under 510(k) number K192694. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PAL Single-Use Cannulas?

PAL Single-Use Cannulas is a medical device that received FDA 510(k) clearance on 2020-05-14. The listed applicant is Microaire Surgical Instruments. The 510(k) number is K192694.

When did PAL Single-Use Cannulas receive FDA 510(k) clearance?

PAL Single-Use Cannulas received FDA 510(k) clearance on 2020-05-14, under 510(k) number K192694.

Who is the listed applicant for PAL Single-Use Cannulas?

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

What is the FDA product code for PAL Single-Use Cannulas?

The FDA product code for PAL Single-Use Cannulas is QPB.

列明Microaire Surgical Instruments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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官方来源

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