FDA 510(k)

MESI mTABLET TBI 腦震傷診斷系統，MESI mTABLET TBI

K 號：K213730 · 2022-04-21

申請人Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.

決定日期2022-04-21

產品代碼JOM

諮詢委員會履歷

決定相當於

器材摘要

MESI mTABLET TBI diagnostic system, MESI mTABLET TBI is the device name listed in this FDA 510(k) record. The listed applicant is Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.. It received FDA 510(k) clearance on 2022-04-21 under 510(k) number K213730. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MESI mTABLET TBI diagnostic system, MESI mTABLET TBI?

MESI mTABLET TBI diagnostic system, MESI mTABLET TBI is a medical device that received FDA 510(k) clearance on 2022-04-21. The listed applicant is Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.. The 510(k) number is K213730.

When did MESI mTABLET TBI diagnostic system, MESI mTABLET TBI receive FDA 510(k) clearance?

MESI mTABLET TBI diagnostic system, MESI mTABLET TBI received FDA 510(k) clearance on 2022-04-21, under 510(k) number K213730.

Who is the listed applicant for MESI mTABLET TBI diagnostic system, MESI mTABLET TBI?

The FDA 510(k) record lists Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MESI mTABLET TBI diagnostic system, MESI mTABLET TBI?

The FDA product code for MESI mTABLET TBI diagnostic system, MESI mTABLET TBI is JOM.

其他以 Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. 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。

K223670MESI mTablet ECG 診斷系統，MESI mTablet ECG

相關器械（代碼：JOM）

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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官方來源

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