FDA 510(k)

DEKA注液システム、DEKA投与セット

K番号: K242693 · 2024-10-07

申請者Deka Research and Development Corporation

決定日2024-10-07

製品コードLDR

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

DEKA Infusion System, DEKA Administration Set is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research and Development Corporation. It received FDA 510(k) clearance on 2024-10-07 under 510(k) number K242693. The device is classified under product code LDR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the DEKA Infusion System, DEKA Administration Set?

DEKA Infusion System, DEKA Administration Set is a medical device that received FDA 510(k) clearance on 2024-10-07. The listed applicant is Deka Research and Development Corporation. The 510(k) number is K242693.

When did DEKA Infusion System, DEKA Administration Set receive FDA 510(k) clearance?

DEKA Infusion System, DEKA Administration Set received FDA 510(k) clearance on 2024-10-07, under 510(k) number K242693.

Who is the listed applicant for DEKA Infusion System, DEKA Administration Set?

The FDA 510(k) record lists Deka Research and Development Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEKA Infusion System, DEKA Administration Set?

The FDA product code for DEKA Infusion System, DEKA Administration Set is LDR.

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DEKA注液システム、DEKA投与セット

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：LDR）

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