FDA 510(k)

MR 5300和MR 7700 R11 MR系统

K号: K223442 · 2022-12-23

申请人Philips Medical Systems Nederlands B.V.

决定日期2022-12-23

产品代码LNH

咨询委员会RA

决定实质等同

器械摘要

MR 5300 and MR 7700 R11 MR Systems is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederlands B.V.. It received FDA 510(k) clearance on 2022-12-23 under 510(k) number K223442. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MR 5300 and MR 7700 R11 MR Systems?

MR 5300 and MR 7700 R11 MR Systems is a medical device that received FDA 510(k) clearance on 2022-12-23. The listed applicant is Philips Medical Systems Nederlands B.V.. The 510(k) number is K223442.

When did MR 5300 and MR 7700 R11 MR Systems receive FDA 510(k) clearance?

MR 5300 and MR 7700 R11 MR Systems received FDA 510(k) clearance on 2022-12-23, under 510(k) number K223442.

Who is the listed applicant for MR 5300 and MR 7700 R11 MR Systems?

The FDA 510(k) record lists Philips Medical Systems Nederlands B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MR 5300 and MR 7700 R11 MR Systems?

The FDA product code for MR 5300 and MR 7700 R11 MR Systems is LNH.

列明Philips Medical Systems Nederlands B.V.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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