FDA 510(k)

単回使用手術吸引器灌洗装置

K番号: K161421 · 2016-06-24

申請者Jiangsu Haize Medical Scientific Development Co., Ltd.

決定日2016-06-24

製品コードGCJ

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定大幅同等

医療機器の概要

Single Use Surgical Suction Irrigator is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Haize Medical Scientific Development Co., Ltd.. It received FDA 510(k) clearance on 2016-06-24 under 510(k) number K161421. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Single Use Surgical Suction Irrigator?

Single Use Surgical Suction Irrigator is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is Jiangsu Haize Medical Scientific Development Co., Ltd.. The 510(k) number is K161421.

When did Single Use Surgical Suction Irrigator receive FDA 510(k) clearance?

Single Use Surgical Suction Irrigator received FDA 510(k) clearance on 2016-06-24, under 510(k) number K161421.

Who is the listed applicant for Single Use Surgical Suction Irrigator?

The FDA 510(k) record lists Jiangsu Haize Medical Scientific Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Surgical Suction Irrigator?

The FDA product code for Single Use Surgical Suction Irrigator is GCJ.

申請者としてJiangsu Haize Medical Scientific Development Co., Ltd.を記載するその他の記録

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