FDA 510(k)

単回使用用の無菌注射器（針付き/針なし）

K番号: K211211 · 2021-10-07

決定日2021-10-07

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 syringes for single use with/without needle 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 2021-10-07 under 510(k) number K211211. 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 syringes for single use with/without needle?

Sterile syringes for single use with/without needle is a medical device that received FDA 510(k) clearance on 2021-10-07. The listed applicant is Azur Medical Company, Inc.. The 510(k) number is K211211.

When did Sterile syringes for single use with/without needle receive FDA 510(k) clearance?

Sterile syringes for single use with/without needle received FDA 510(k) clearance on 2021-10-07, under 510(k) number K211211.

Who is the listed applicant for Sterile syringes for single use with/without needle?

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 syringes for single use with/without needle?

The FDA product code for Sterile syringes for single use with/without needle 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 K211210無菌自動停止注射器（針付き/針なし、単回使用用）K211214単回使用用無菌皮下注射針

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