FDA 510(k)

阻斷檢測敷料套件

K 號：K171499 · 2017-09-22

決定日期2017-09-22

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

Occlusion Detection Dressing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Cardinalhealth. It received FDA 510(k) clearance on 2017-09-22 under 510(k) number K171499. 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 Occlusion Detection Dressing Kit?

Occlusion Detection Dressing Kit is a medical device that received FDA 510(k) clearance on 2017-09-22. The listed applicant is Cardinalhealth. The 510(k) number is K171499.

When did Occlusion Detection Dressing Kit receive FDA 510(k) clearance?

Occlusion Detection Dressing Kit received FDA 510(k) clearance on 2017-09-22, under 510(k) number K171499.

Who is the listed applicant for Occlusion Detection Dressing Kit?

FDA 510(k) 記錄將 Cardinalhealth 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Occlusion Detection Dressing Kit?

The FDA product code for Occlusion Detection Dressing Kit is OMP.

其他以 Cardinalhealth 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。

K261749卡迪那爾健康公司尼龍藍色檢查手套，已經通過與化學療法藥物和芬太尼鹽酸鹽的測試。K252313卡迪那爾健康公司硅膠檢查手套長袖 K243660Monoject™ 1mL結核菌素針筒 Luer-Lock尖端 (1180100777)；Monoject™ 3mL針筒，Luer-Lock尖端 (1180300777)；Monoject™ 6mL針筒，Luer-Lock尖端 (1180600777)；Monoject™ 12mL針筒，Luer-Lock尖端 (1181200777)；Monoject™ 20mL針筒，Luer-Lock尖端 (1182000777)；Monoject™ 35mL針筒，Luer-Lock尖端 (1183500777)；Monoject™ 60mL針筒，Luer-Lock尖端 (1186000777)；Monoject™ 3mL針筒，Luer-Lock尖端 (8881513934)；Monoject™ 6mL針筒，Luer-Lock尖端 (8881516937)；Monojec K243652Monoject™ 飲食針筒配ENFit連接器（401SE）；Monoject™ 飲食針筒配ENFit連接器（403SE）；Monoject™ 飲食針筒配ENFit連接器（406SE）；Monoject™ 飲食針筒配ENFit連接器（412SE）；Monoject™ 飲食針筒配ENFit連接器（435SE）；Monoject™ 飲食針筒配ENFit連接器（460SE）K230569卡迪那爾健康外科口罩防霧水凝膠 (3級)；卡迪那爾健康外科口罩防霧水凝膠 (1級)K213174塞勒姆雙腔胃管用ENFit連接硅胶胃管

查看所有 11 項裝置 →

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。