FDA 510(k)

心臟工作站（5000）；心臟工作站（7000）

K 號：K241556 · 2024-12-17

申請人Philips Medizin Systeme Böblingen GmbH

決定日期2024-12-17

產品代碼DPS

諮詢委員會履歷

決定相當於

器材摘要

Cardiac Workstation (5000); Cardiac Workstation (7000) is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medizin Systeme Böblingen GmbH. It received FDA 510(k) clearance on 2024-12-17 under 510(k) number K241556. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cardiac Workstation (5000); Cardiac Workstation (7000)?

Cardiac Workstation (5000); Cardiac Workstation (7000) is a medical device that received FDA 510(k) clearance on 2024-12-17. The listed applicant is Philips Medizin Systeme Böblingen GmbH. The 510(k) number is K241556.

When did Cardiac Workstation (5000); Cardiac Workstation (7000) receive FDA 510(k) clearance?

Cardiac Workstation (5000); Cardiac Workstation (7000) received FDA 510(k) clearance on 2024-12-17, under 510(k) number K241556.

Who is the listed applicant for Cardiac Workstation (5000); Cardiac Workstation (7000)?

The FDA 510(k) record lists Philips Medizin Systeme Böblingen GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cardiac Workstation (5000); Cardiac Workstation (7000)?

The FDA product code for Cardiac Workstation (5000); Cardiac Workstation (7000) is DPS.

其他以 Philips Medizin Systeme Böblingen GmbH 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。

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相關器械（代碼：DPS）

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。

K254255S-Patch 心臟AIWellysis Corp.K252463SE-1202系列心電圖儀（型號：SE-1202，SE-1202E）Edan Instruments, Inc.K251670MAC 7 靜息心電圖分析系統Ge Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)Withings K250569Cardiologs 霍爾特平台Philips France Commercial

官方來源

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