FDA 510(k)

遙測監視器 5500 版本 4.0 (867232)

K 號：K242962 · 2025-05-05

申請人Philips Medizin Systeme Böblingen GmbH

決定日期2025-05-05

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

Telemetry Monitor 5500 Release 4.0 (867232) 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 2025-05-05 under 510(k) number K242962. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Telemetry Monitor 5500 Release 4.0 (867232)?

Telemetry Monitor 5500 Release 4.0 (867232) is a medical device that received FDA 510(k) clearance on 2025-05-05. The listed applicant is Philips Medizin Systeme Böblingen GmbH. The 510(k) number is K242962.

When did Telemetry Monitor 5500 Release 4.0 (867232) receive FDA 510(k) clearance?

Telemetry Monitor 5500 Release 4.0 (867232) received FDA 510(k) clearance on 2025-05-05, under 510(k) number K242962.

Who is the listed applicant for Telemetry Monitor 5500 Release 4.0 (867232)?

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 Telemetry Monitor 5500 Release 4.0 (867232)?

The FDA product code for Telemetry Monitor 5500 Release 4.0 (867232) is MHX.

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：MHX）

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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