FDA 510(k)

診断X線システム/PLX5200A

K番号: K212134 · 2021-08-25

申請者Nanjing Perlove Medical Equipment Co., Ltd.

決定日2021-08-25

製品コードIZL

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてNanjing Perlove Medical Equipment Co., Ltd.を記載するその他の記録

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