FDA 510(k)

BCM2-Body Composition Monitor

K 號：K250634 · 2025-11-24

申請人Fresenius Medical Care Renal Therapies Group, LLC

決定日期2025-11-24

產品代碼DSB

諮詢委員會履歷

決定相當於

器材摘要

BCM2-Body Composition Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2025-11-24 under 510(k) number K250634. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BCM2-Body Composition Monitor?

BCM2-Body Composition Monitor is a medical device that received FDA 510(k) clearance on 2025-11-24. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K250634.

When did BCM2-Body Composition Monitor receive FDA 510(k) clearance?

BCM2-Body Composition Monitor received FDA 510(k) clearance on 2025-11-24, under 510(k) number K250634.

Who is the listed applicant for BCM2-Body Composition Monitor?

FDA 510(k) 記錄中將 Fresenius Medical Care Renal Therapies Group, LLC 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for BCM2-Body Composition Monitor?

The FDA product code for BCM2-Body Composition Monitor is DSB.

其他以 Fresenius Medical Care Renal Therapies Group, LLC 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。

K261267Careflux H60；Careflux H70；Careflux V500 K252377NxStage System One 配 NxView K252459multiFlux 130 (F00013123)；multiFlux 160 (F00013124)K253462NaturaLyte®乾性重碳濃縮液（08-4112-2）K253518FX珊瑚40；FX珊瑚50 K250471AquaC UNO H

查看所有 48 項裝置 →

相關器械（代碼：DSB）

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。

K260224MySOZO軟體版本6.1.0.1（軟體版本6.1.0.1）ImpediMed Limited K243727關於Balans醫療設備規範文本 Re:BalansMode Sensors AS K250922腫脹守護監測器（EGM） cardioSet-001Cardioset Medical , Ltd.K232089SOZO ProImpediMed Limited K223217Zynex監控系統，型號CM-1600Zynex Medical, Inc.K211585Bodyport 心臟秤Bodyport, 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。