FDA 510(k)

诊断型X射线系统

K号: K243411 · 2025-05-19

申请人Nanjing Perlove Medical Equipment Co., Ltd.

决定日期2025-05-19

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

Diagnostic X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Perlove Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-05-19 under 510(k) number K243411. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Diagnostic X-ray System?

Diagnostic X-ray System is a medical device that received FDA 510(k) clearance on 2025-05-19. The listed applicant is Nanjing Perlove Medical Equipment Co., Ltd.. The 510(k) number is K243411.

When did Diagnostic X-ray System receive FDA 510(k) clearance?

Diagnostic X-ray System received FDA 510(k) clearance on 2025-05-19, under 510(k) number K243411.

Who is the listed applicant for Diagnostic X-ray System?

The FDA 510(k) record lists Nanjing Perlove Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diagnostic X-ray System?

The FDA product code for Diagnostic X-ray System is OWB.

列明Nanjing Perlove Medical Equipment Co., Ltd.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。

K212134诊断型X射线系统/PLX5200A

官方来源

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