FDA 510(k)

無菌注射針付き注射器

K番号: K211753 · 2021-10-14

申請者Jiangxi Hongda Medical Equipment Group , Ltd.

決定日2021-10-14

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 Syringe With Safety Needle 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 2021-10-14 under 510(k) number K211753. 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 Syringe With Safety Needle?

Sterile Syringe With Safety Needle is a medical device that received FDA 510(k) clearance on 2021-10-14. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. The 510(k) number is K211753.

When did Sterile Syringe With Safety Needle receive FDA 510(k) clearance?

Sterile Syringe With Safety Needle received FDA 510(k) clearance on 2021-10-14, under 510(k) number K211753.

Who is the listed applicant for Sterile Syringe With Safety Needle?

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 Syringe With Safety Needle?

The FDA product code for Sterile Syringe With Safety Needle 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

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 K163162単回使用用無菌皮下注射安全性注射器 K163161無菌単回使用注射器および針

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。