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FDA 510(k)

尼素觸觸負壓創傷治療泵

K 號:K203693 · 2021-08-13

決定日期2021-08-13
產品代碼OMP
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

Nisus Touch Negative Pressure Wound Therapy Pump is the device name listed in this FDA 510(k) record. The listed applicant is Cork Medical Products, LLC. It received FDA 510(k) clearance on 2021-08-13 under 510(k) number K203693. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nisus Touch Negative Pressure Wound Therapy Pump?

Nisus Touch Negative Pressure Wound Therapy Pump is a medical device that received FDA 510(k) clearance on 2021-08-13. The listed applicant is Cork Medical Products, LLC. The 510(k) number is K203693.

When did Nisus Touch Negative Pressure Wound Therapy Pump receive FDA 510(k) clearance?

Nisus Touch Negative Pressure Wound Therapy Pump received FDA 510(k) clearance on 2021-08-13, under 510(k) number K203693.

Who is the listed applicant for Nisus Touch Negative Pressure Wound Therapy Pump?

The FDA 510(k) record lists Cork Medical Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nisus Touch Negative Pressure Wound Therapy Pump?

The FDA product code for Nisus Touch Negative Pressure Wound Therapy Pump is OMP.

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相關器械(代碼:OMP)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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