FDA 510(k)

V.A.C.ULTA 負壓創口治療系統

K 號：K162790 · 2017-01-26

申請人Kci USA, Inc. (Kinetic Concepts, Inc.)

決定日期2017-01-26

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

V.A.C.ULTA Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Kci USA, Inc. (Kinetic Concepts, Inc.). It received FDA 510(k) clearance on 2017-01-26 under 510(k) number K162790. 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 V.A.C.ULTA Negative Pressure Wound Therapy System?

V.A.C.ULTA Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2017-01-26. The listed applicant is Kci USA, Inc. (Kinetic Concepts, Inc.). The 510(k) number is K162790.

When did V.A.C.ULTA Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

V.A.C.ULTA Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2017-01-26, under 510(k) number K162790.

Who is the listed applicant for V.A.C.ULTA Negative Pressure Wound Therapy System?

The FDA 510(k) record lists Kci USA, Inc. (Kinetic Concepts, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for V.A.C.ULTA Negative Pressure Wound Therapy System?

The FDA product code for V.A.C.ULTA Negative Pressure Wound Therapy System is OMP.

其他以 Kci USA, Inc. (Kinetic Concepts, Inc.) 為申請人之記錄

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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。

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