FDA 510(k)

TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))

K番号: K231856 · 2024-03-15

決定日2024-03-15

製品コードQNQ

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

TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) is the device name listed in this FDA 510(k) record. The listed applicant is Medexel Co.,Ltd. It received FDA 510(k) clearance on 2024-03-15 under 510(k) number K231856. The device is classified under product code QNQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))?

TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) is a medical device that received FDA 510(k) clearance on 2024-03-15. The listed applicant is Medexel Co.,Ltd. The 510(k) number is K231856.

When did TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) receive FDA 510(k) clearance?

TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) received FDA 510(k) clearance on 2024-03-15, under 510(k) number K231856.

Who is the listed applicant for TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))?

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

What is the FDA product code for TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))?

The FDA product code for TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) is QNQ.

申請者としてMedexel Co.,Ltdを記載するその他の記録

K172095オートキーパー K152410Top Fine Pen Needle

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