FDA 510(k)

開感器X系列

K 號：K220556 · 2022-04-13

決定日期2022-04-13

產品代碼MUH

諮詢委員會DE

決定相當於

器材摘要

OpenSensorX Series is the device name listed in this FDA 510(k) record. The listed applicant is Dentimax, Inc.. It received FDA 510(k) clearance on 2022-04-13 under 510(k) number K220556. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OpenSensorX Series?

OpenSensorX Series is a medical device that received FDA 510(k) clearance on 2022-04-13. The listed applicant is Dentimax, Inc.. The 510(k) number is K220556.

When did OpenSensorX Series receive FDA 510(k) clearance?

OpenSensorX Series received FDA 510(k) clearance on 2022-04-13, under 510(k) number K220556.

Who is the listed applicant for OpenSensorX Series?

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

What is the FDA product code for OpenSensorX Series?

The FDA product code for OpenSensorX Series is MUH.

其他以 Dentimax, Inc. 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。

K251206數位X光牙科DentiMax Pro影像系統

相關器械（代碼：MUH）

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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