FDA 510(k)

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K番号: K172578 · 2017-12-07

申請者Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd

決定日2017-12-07

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

Equipment Pouch is the device name listed in this FDA 510(k) record. The listed applicant is Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. It received FDA 510(k) clearance on 2017-12-07 under 510(k) number K172578. 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 Equipment Pouch?

Equipment Pouch is a medical device that received FDA 510(k) clearance on 2017-12-07. The listed applicant is Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. The 510(k) number is K172578.

When did Equipment Pouch receive FDA 510(k) clearance?

Equipment Pouch received FDA 510(k) clearance on 2017-12-07, under 510(k) number K172578.

Who is the listed applicant for Equipment Pouch?

The FDA 510(k) record lists Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Equipment Pouch?

The FDA product code for Equipment Pouch is GCJ.

申請者としてWickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltdを記載するその他の記録

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