FDA 510(k)

AIR Recon DL

K号: K213717 · 2022-06-08

申请人Ge Medical Systems,Llc (Ge Healthcare)

决定日期2022-06-08

产品代码LNH

咨询委员会RA

决定实质等同

器械摘要

AIR Recon DL is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems,Llc (Ge Healthcare). It received FDA 510(k) clearance on 2022-06-08 under 510(k) number K213717. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

什么是AIR Recon DL？

AIR Recon DL is a medical device that received FDA 510(k) clearance on 2022-06-08. The listed applicant is Ge Medical Systems,Llc (Ge Healthcare). The 510(k) number is K213717.

AIR Recon DL何时获得FDA 510(k)批准？

AIR Recon DL received FDA 510(k) clearance on 2022-06-08, under 510(k) number K213717.

谁是AIR Recon DL的列名申请人？

The FDA 510(k) record lists Ge Medical Systems,Llc (Ge Healthcare) as the applicant. This does not by itself establish the device manufacturer.

什么是AIR Recon DL的FDA产品代码？

FDA产品代码为AIR Recon DL的是LNH。

列明Ge Medical Systems,Llc (Ge Healthcare)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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