FDA 510(k)

诊断型X射线系统/PLX5200A

K号: K212134 · 2021-08-25

申请人Nanjing Perlove Medical Equipment Co., Ltd.

决定日期2021-08-25

产品代码IZL

咨询委员会RA

决定实质等同

器械摘要

Diagnostic X-ray System/PLX5200A 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 2021-08-25 under 510(k) number K212134. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Diagnostic X-ray System/PLX5200A?

Diagnostic X-ray System/PLX5200A is a medical device that received FDA 510(k) clearance on 2021-08-25. The listed applicant is Nanjing Perlove Medical Equipment Co., Ltd.. The 510(k) number is K212134.

When did Diagnostic X-ray System/PLX5200A receive FDA 510(k) clearance?

Diagnostic X-ray System/PLX5200A received FDA 510(k) clearance on 2021-08-25, under 510(k) number K212134.

Who is the listed applicant for Diagnostic X-ray System/PLX5200A?

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/PLX5200A?

The FDA product code for Diagnostic X-ray System/PLX5200A is IZL.

列明Nanjing Perlove Medical Equipment Co., Ltd.为申报人的其他记录

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K243411诊断型X射线系统

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