FDA 510(k)

無菌単回使用先端クリーナー（WK800-S10 、WK800-S20）

K番号: K241022 · 2024-07-11

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

決定日2024-07-11

製品コードGEI

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Sterile single use tip cleaner (WK800-S10 , WK800-S20) 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 2024-07-11 under 510(k) number K241022. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Sterile single use tip cleaner (WK800-S10 , WK800-S20)?

Sterile single use tip cleaner (WK800-S10 , WK800-S20) is a medical device that received FDA 510(k) clearance on 2024-07-11. The listed applicant is Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. The 510(k) number is K241022.

When did Sterile single use tip cleaner (WK800-S10 , WK800-S20) receive FDA 510(k) clearance?

Sterile single use tip cleaner (WK800-S10 , WK800-S20) received FDA 510(k) clearance on 2024-07-11, under 510(k) number K241022.

Who is the listed applicant for Sterile single use tip cleaner (WK800-S10 , WK800-S20)?

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 Sterile single use tip cleaner (WK800-S10 , WK800-S20)?

The FDA product code for Sterile single use tip cleaner (WK800-S10 , WK800-S20) is GEI.

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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