FDA 510(k)

M12 遥測系統

K 號：K252840 · 2026-05-29

決定日期2026-05-29

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

M12 Telemetry System is the device name listed in this FDA 510(k) record. The listed applicant is Global Instrumentation, LLC. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K252840. 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 M12 Telemetry System?

M12 Telemetry System is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is Global Instrumentation, LLC. The 510(k) number is K252840.

When did M12 Telemetry System receive FDA 510(k) clearance?

M12 Telemetry System received FDA 510(k) clearance on 2026-05-29, under 510(k) number K252840.

Who is the listed applicant for M12 Telemetry System?

The FDA 510(k) record lists Global Instrumentation, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M12 Telemetry System?

The FDA product code for M12 Telemetry System is MHX.

其他以 Global Instrumentation, 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。

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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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