FDA 510(k)

自動踝壓脈壓指數測量設備，MESI mTABLET 系統

K 號：K201046 · 2020-12-11

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

決定日期2020-12-11

產品代碼JOM

諮詢委員會履歷

決定相當於

器材摘要

Automated ankle brachial pressure index measuring device, MESI mTABLET system is the device name listed in this FDA 510(k) record. The listed applicant is Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.. It received FDA 510(k) clearance on 2020-12-11 under 510(k) number K201046. 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 Automated ankle brachial pressure index measuring device, MESI mTABLET system?

Automated ankle brachial pressure index measuring device, MESI mTABLET system is a medical device that received FDA 510(k) clearance on 2020-12-11. The listed applicant is Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.. The 510(k) number is K201046.

When did Automated ankle brachial pressure index measuring device, MESI mTABLET system receive FDA 510(k) clearance?

Automated ankle brachial pressure index measuring device, MESI mTABLET system received FDA 510(k) clearance on 2020-12-11, under 510(k) number K201046.

Who is the listed applicant for Automated ankle brachial pressure index measuring device, MESI mTABLET system?

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

What is the FDA product code for Automated ankle brachial pressure index measuring device, MESI mTABLET system?

The FDA product code for Automated ankle brachial pressure index measuring device, MESI mTABLET system is JOM.

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

K172655自動踝壓脈壓指數測量設備

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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