FDA 510(k)

ニスス・タッチネガティブプレッシャー準天炎治療ポンプ

K番号: K203693 · 2021-08-13

決定日2021-08-13

製品コードOMP

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

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.

よくある質問

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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ニスス・タッチネガティブプレッシャー準天炎治療ポンプ

医療機器の概要

よくある質問

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