FDA 510(k)

Tablo血液透析系統

K 號：K200741 · 2020-03-31

決定日期2020-03-31

產品代碼KDI

諮詢委員會GU

決定相當於

器材摘要

Tablo Hemodialysis System is the device name listed in this FDA 510(k) record. The listed applicant is Outset Medical, Inc.. It received FDA 510(k) clearance on 2020-03-31 under 510(k) number K200741. 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 Tablo Hemodialysis System?

Tablo Hemodialysis System is a medical device that received FDA 510(k) clearance on 2020-03-31. The listed applicant is Outset Medical, Inc.. The 510(k) number is K200741.

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

Tablo Hemodialysis System received FDA 510(k) clearance on 2020-03-31, under 510(k) number K200741.

Who is the listed applicant for Tablo Hemodialysis System?

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

What is the FDA product code for Tablo Hemodialysis System?

The FDA product code for Tablo Hemodialysis System is KDI.

其他以 Outset Medical, 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。

K253412Tablo血液透析系統（PN-0008000，PN-0006000U）K232776Tablo®血液透析系統；TabloCart™ 配有預過濾抽屜 K233335Tablo® 靜脈透析系統 K223248Tablo® 靜脈透析系統 K211370Tablo血液透析系統 K210782Tablo 壳蓋

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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

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