FDA 510(k)

Surdial DX 血液透析系統

K 號：K182940 · 2019-07-19

決定日期2019-07-19

產品代碼KDI

諮詢委員會GU

決定相當於

器材摘要

Surdial DX Hemodialysis System is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Medical Corporation. It received FDA 510(k) clearance on 2019-07-19 under 510(k) number K182940. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Surdial DX Hemodialysis System?

Surdial DX Hemodialysis System is a medical device that received FDA 510(k) clearance on 2019-07-19. The listed applicant is Nipro Medical Corporation. The 510(k) number is K182940.

When did Surdial DX Hemodialysis System receive FDA 510(k) clearance?

Surdial DX Hemodialysis System received FDA 510(k) clearance on 2019-07-19, under 510(k) number K182940.

Who is the listed applicant for Surdial DX Hemodialysis System?

FDA 510(k) 記錄中將 Nipro 医療公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Surdial DX Hemodialysis System?

The FDA product code for Surdial DX Hemodialysis System is KDI.

其他以 Nipro Medical 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。

K261399ELISIO™-HX K253047壓一通™K260533ELISIO™-H K222852尼普洛安全觸針針筒；尼普洛配安全觸針注射器 K212677aboNT 靜脈注射器 K190037克洛諾斯HP PTA 機械導管球囊

查看所有 12 項裝置 →

相關器械（代碼：KDI）

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。

K261267Careflux H60；Careflux H70；Careflux V500Fresenius Medical Care Renal Therapies Group, LLC K252377NxStage System One 配 NxViewFresenius Medical Care Renal Therapies Group, LLC K260533ELISIO™-HNipro Medical Corporation K252459multiFlux 130 (F00013123)；multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC K253412Tablo血液透析系統（PN-0008000，PN-0006000U）Outset Medical, Inc.K253518FX珊瑚40；FX珊瑚50Fresenius Medical Care Renal Therapies Group, LLC

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。