FDA 510(k)

ライントランス・ブリッドランシング・システム

K番号: K222034 · 2022-09-07

申請者Beijing Ruicheng Medical Supplies Co., Ltd.

決定日2022-09-07

製品コードQRL

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

RightLance Blood Lancing System is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Ruicheng Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2022-09-07 under 510(k) number K222034. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the RightLance Blood Lancing System?

RightLance Blood Lancing System is a medical device that received FDA 510(k) clearance on 2022-09-07. The listed applicant is Beijing Ruicheng Medical Supplies Co., Ltd.. The 510(k) number is K222034.

When did RightLance Blood Lancing System receive FDA 510(k) clearance?

RightLance Blood Lancing System received FDA 510(k) clearance on 2022-09-07, under 510(k) number K222034.

Who is the listed applicant for RightLance Blood Lancing System?

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

What is the FDA product code for RightLance Blood Lancing System?

The FDA product code for RightLance Blood Lancing System is QRL.

申請者としてBeijing Ruicheng Medical Supplies Co., Ltd.を記載するその他の記録

K222408使い捨て安全注射針

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。