FDA 510(k)

UNO 負壓創傷治療系統

K 號：K161599 · 2017-04-06

決定日期2017-04-06

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

UNO Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Genadyne Biotechnologies, Inc.. It received FDA 510(k) clearance on 2017-04-06 under 510(k) number K161599. 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 UNO Negative Pressure Wound Therapy System?

UNO Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2017-04-06. The listed applicant is Genadyne Biotechnologies, Inc.. The 510(k) number is K161599.

When did UNO Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

UNO Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2017-04-06, under 510(k) number K161599.

Who is the listed applicant for UNO Negative Pressure Wound Therapy System?

The FDA 510(k) record lists Genadyne Biotechnologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNO Negative Pressure Wound Therapy System?

The FDA product code for UNO Negative Pressure Wound Therapy System is OMP.

其他以 Genadyne Biotechnologies, Inc. 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。

K253429Genadyne ASTRA NPWT K243225鼻枕口罩 - 小型 (NNPM-01/ Nefes S)；鼻枕口罩 - 中型 (NNPM-02/ Nefes M)；鼻枕口罩 - 大型 (NNPM-03/ Nefes L)K233614Genadyne 杜歐 NPWT K221888Genadyne 混合泡沫敷料 K221891UNO 負壓創傷治療系統 K210107Genadyne UNO Plus (UNO+) 負壓創傷治療系統

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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。

K261338RENASYS DYNAFLOW 套件（66807741）Smith & Nephew Medical, Ltd.K253263ConvaVAC™ 負壓傷口治療系統Convatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT 內容器 500-mL (CPC-500)Cork Medical K254019傷口基因NPWT系統Bechtel Medical, Inc.

官方來源

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