FDA 510(k)

PAL吸引系统

K号: K242804 · 2024-12-30

决定日期2024-12-30

产品代码QPB

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决定实质等同

器械摘要

PAL Aspiration System is the device name listed in this FDA 510(k) record. The listed applicant is Microaire Surgical Instruments, LLC. It received FDA 510(k) clearance on 2024-12-30 under 510(k) number K242804. 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 Aspiration System?

PAL Aspiration System is a medical device that received FDA 510(k) clearance on 2024-12-30. The listed applicant is Microaire Surgical Instruments, LLC. The 510(k) number is K242804.

When did PAL Aspiration System receive FDA 510(k) clearance?

PAL Aspiration System received FDA 510(k) clearance on 2024-12-30, under 510(k) number K242804.

Who is the listed applicant for PAL Aspiration System?

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

What is the FDA product code for PAL Aspiration System?

The FDA product code for PAL Aspiration System is QPB.

列明Microaire Surgical Instruments, LLC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。

K243589PAL灭菌盒 K244026PAL 7020控制台 K220318PAL浸润系统 K212024PAL系统 K181819SMARTRELEASE 内窥镜软组织释放系统 K171286PAL多用途导管和PAL手动棒

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。