FDA 510(k)

STERiJECT 低死空間、STERiJECT 見えない針

K番号: K231734 · 2024-03-08

申請者Tsk Laboratory International Japan KK

決定日2024-03-08

製品コードQNS

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

STERiJECT Low Dead Space, STERiJECT The Invisible Needle is the device name listed in this FDA 510(k) record. The listed applicant is Tsk Laboratory International Japan KK. It received FDA 510(k) clearance on 2024-03-08 under 510(k) number K231734. The device is classified under product code QNS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the STERiJECT Low Dead Space, STERiJECT The Invisible Needle?

STERiJECT Low Dead Space, STERiJECT The Invisible Needle is a medical device that received FDA 510(k) clearance on 2024-03-08. The listed applicant is Tsk Laboratory International Japan KK. The 510(k) number is K231734.

When did STERiJECT Low Dead Space, STERiJECT The Invisible Needle receive FDA 510(k) clearance?

STERiJECT Low Dead Space, STERiJECT The Invisible Needle received FDA 510(k) clearance on 2024-03-08, under 510(k) number K231734.

Who is the listed applicant for STERiJECT Low Dead Space, STERiJECT The Invisible Needle?

The FDA 510(k) record lists Tsk Laboratory International Japan KK as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERiJECT Low Dead Space, STERiJECT The Invisible Needle?

The FDA product code for STERiJECT Low Dead Space, STERiJECT The Invisible Needle is QNS.

申請者としてTsk Laboratory International Japan KKを記載するその他の記録

K242073STERiJECT 眼科針；STERiJECT 眼科針低死空間（LDS）

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。