FDA 510(k)

Anscare SIMO 負壓創傷治療系統 (NPWT)

K 號：K193185 · 2020-05-04

決定日期2020-05-04

產品代碼OKO

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

Anscare SIMO Negative Pressure Wound Therapy (NPWT) System is the device name listed in this FDA 510(k) record. The listed applicant is Benq Materials Corporation. It received FDA 510(k) clearance on 2020-05-04 under 510(k) number K193185. The device is classified under product code OKO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Anscare SIMO Negative Pressure Wound Therapy (NPWT) System?

Anscare SIMO Negative Pressure Wound Therapy (NPWT) System is a medical device that received FDA 510(k) clearance on 2020-05-04. The listed applicant is Benq Materials Corporation. The 510(k) number is K193185.

When did Anscare SIMO Negative Pressure Wound Therapy (NPWT) System receive FDA 510(k) clearance?

Anscare SIMO Negative Pressure Wound Therapy (NPWT) System received FDA 510(k) clearance on 2020-05-04, under 510(k) number K193185.

Who is the listed applicant for Anscare SIMO Negative Pressure Wound Therapy (NPWT) System?

The FDA 510(k) record lists Benq Materials Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anscare SIMO Negative Pressure Wound Therapy (NPWT) System?

The FDA product code for Anscare SIMO Negative Pressure Wound Therapy (NPWT) System is OKO.

其他以 Benq Materials Corporation 為申請人之記錄

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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相關器械（代碼：OKO）

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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