FDA 510(k)

単回使用用無菌皮下注射安全性注射器

K番号: K163162 · 2017-03-20

申請者Jiangxi Hongda Medical Equipment Group , Ltd.

決定日2017-03-20

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]

決定大幅同等

医療機器の概要

Sterile Hypodermic Safety Syringes for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. It received FDA 510(k) clearance on 2017-03-20 under 510(k) number K163162. 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 Sterile Hypodermic Safety Syringes for Single Use?

Sterile Hypodermic Safety Syringes for Single Use is a medical device that received FDA 510(k) clearance on 2017-03-20. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. The 510(k) number is K163162.

When did Sterile Hypodermic Safety Syringes for Single Use receive FDA 510(k) clearance?

Sterile Hypodermic Safety Syringes for Single Use received FDA 510(k) clearance on 2017-03-20, under 510(k) number K163162.

Who is the listed applicant for Sterile Hypodermic Safety Syringes for Single Use?

The FDA 510(k) record lists Jiangxi Hongda Medical Equipment Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Hypodermic Safety Syringes for Single Use?

The FDA product code for Sterile Hypodermic Safety Syringes for Single Use is MEG.

申請者としてJiangxi Hongda Medical Equipment Group , Ltd.を記載するその他の記録

K211753無菌注射針付き注射器 K210578医療用ニトリル検査手袋（パワーフリー、青）K210821医療用PVC検査手袋 K163160無菌単回使用インフュージョンセット K163161無菌単回使用注射器および針

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