FDA 510(k)

無菌自動停止注射器（針付き/針なし、単回使用用）

K番号: K211210 · 2022-01-27

決定日2022-01-27

製品コードFMF

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

Sterile Auto-Disable Syringes with/without Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Azur Medical Company, Inc.. It received FDA 510(k) clearance on 2022-01-27 under 510(k) number K211210. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Sterile Auto-Disable Syringes with/without Needle for Single Use?

Sterile Auto-Disable Syringes with/without Needle for Single Use is a medical device that received FDA 510(k) clearance on 2022-01-27. The listed applicant is Azur Medical Company, Inc.. The 510(k) number is K211210.

When did Sterile Auto-Disable Syringes with/without Needle for Single Use receive FDA 510(k) clearance?

Sterile Auto-Disable Syringes with/without Needle for Single Use received FDA 510(k) clearance on 2022-01-27, under 510(k) number K211210.

Who is the listed applicant for Sterile Auto-Disable Syringes with/without Needle for Single Use?

The FDA 510(k) record lists Azur Medical Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Auto-Disable Syringes with/without Needle for Single Use?

The FDA product code for Sterile Auto-Disable Syringes with/without Needle for Single Use is FMF.

申請者としてAzur Medical Company, Inc.を記載するその他の記録

K231719医療用外科マスク K211214単回使用用無菌皮下注射針 K211211単回使用用の無菌注射器（針付き/針なし）

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