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FDA 510(k)

PICO單次使用負壓創口治療系統，PICO 7單次使用負壓創口治療系統，PICO 7Y單次使用負壓創口治療系統，PICO 14單次使用負壓創口治療系統

K 號：K203716 · 2021-12-14

申請人Smith and Nephew Medical Limited
決定日期2021-12-14
產品代碼QFC
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

PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Smith and Nephew Medical Limited. It received FDA 510(k) clearance on 2021-12-14 under 510(k) number K203716. The device is classified under product code QFC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System?

PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2021-12-14. The listed applicant is Smith and Nephew Medical Limited. The 510(k) number is K203716.

When did PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2021-12-14, under 510(k) number K203716.

Who is the listed applicant for PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System?

The FDA 510(k) record lists Smith and Nephew Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System?

The FDA product code for PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System is QFC.

相關臨床試驗

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其他以 Smith and Nephew Medical Limited 為申請人之記錄

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相關器械（代碼：QFC）

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。

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官方來源

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