FDA 510(k)

フラッシュ注射器（充填0.9%正常塩水溶液）

K番号: K231724 · 2023-11-09

決定日2023-11-09

製品コードNGT

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

Flush Syringe (Prefilled 0.9% normal saline solution) is the device name listed in this FDA 510(k) record. The listed applicant is Spm Medicare Pvt. , Ltd.. It received FDA 510(k) clearance on 2023-11-09 under 510(k) number K231724. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Flush Syringe (Prefilled 0.9% normal saline solution)?

Flush Syringe (Prefilled 0.9% normal saline solution) is a medical device that received FDA 510(k) clearance on 2023-11-09. The listed applicant is Spm Medicare Pvt. , Ltd.. The 510(k) number is K231724.

When did Flush Syringe (Prefilled 0.9% normal saline solution) receive FDA 510(k) clearance?

Flush Syringe (Prefilled 0.9% normal saline solution) received FDA 510(k) clearance on 2023-11-09, under 510(k) number K231724.

Who is the listed applicant for Flush Syringe (Prefilled 0.9% normal saline solution)?

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

What is the FDA product code for Flush Syringe (Prefilled 0.9% normal saline solution)?

The FDA product code for Flush Syringe (Prefilled 0.9% normal saline solution) is NGT.

申請者としてSpm Medicare Pvt. , Ltd.を記載するその他の記録

K233794Insulin Syringe

公式ソース

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