FDA 510(k)

Yikang Latex Foley Catheter

K番号: K173340 · 2018-07-13

申請者Jiangxi Yikang Medical Instrument Group Co., Ltd.

決定日2018-07-13

製品コードEZL

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Substantially Equivalent

医療機器の概要

Yikang Latex Foley Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Yikang Medical Instrument Group Co., Ltd.. It received FDA 510(k) clearance on 2018-07-13 under 510(k) number K173340. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Yikang Latex Foley Catheter?

Yikang Latex Foley Catheter is a medical device that received FDA 510(k) clearance on 2018-07-13. The listed applicant is Jiangxi Yikang Medical Instrument Group Co., Ltd.. The 510(k) number is K173340.

When did Yikang Latex Foley Catheter receive FDA 510(k) clearance?

Yikang Latex Foley Catheter received FDA 510(k) clearance on 2018-07-13, under 510(k) number K173340.

Who is the listed applicant for Yikang Latex Foley Catheter?

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

What is the FDA product code for Yikang Latex Foley Catheter?

The FDA product code for Yikang Latex Foley Catheter is EZL.

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

K190213Yikang Endotracheal Tube

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