FDA 510(k)

Shina Syringe; Shina Safety Syringe

K番号: K231165 · 2023-10-27

決定日2023-10-27

製品コードMEG

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Substantially Equivalent

医療機器の概要

Shina Syringe; Shina Safety Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Shina Med Corporation. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K231165. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Shina Syringe; Shina Safety Syringe?

Shina Syringe; Shina Safety Syringe is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is Shina Med Corporation. The 510(k) number is K231165.

When did Shina Syringe; Shina Safety Syringe receive FDA 510(k) clearance?

Shina Syringe; Shina Safety Syringe received FDA 510(k) clearance on 2023-10-27, under 510(k) number K231165.

Who is the listed applicant for Shina Syringe; Shina Safety Syringe?

The FDA 510(k) record lists Shina Med Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Shina Syringe; Shina Safety Syringe?

The FDA product code for Shina Syringe; Shina Safety Syringe is MEG.

申請者としてShina Med Corporationを記載するその他の記録

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