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FDA 510(k)

TIO-H數位X光感測器

K 號:K153144 · 2016-02-10

申請人Denttio, Inc.
決定日期2016-02-10
產品代碼MUH
諮詢委員會DE
決定相當於

器材摘要

TIO-H DIGITAL RADIOGRAPHY SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Denttio, Inc.. It received FDA 510(k) clearance on 2016-02-10 under 510(k) number K153144. 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 TIO-H DIGITAL RADIOGRAPHY SENSOR?

TIO-H DIGITAL RADIOGRAPHY SENSOR is a medical device that received FDA 510(k) clearance on 2016-02-10. The listed applicant is Denttio, Inc.. The 510(k) number is K153144.

When did TIO-H DIGITAL RADIOGRAPHY SENSOR receive FDA 510(k) clearance?

TIO-H DIGITAL RADIOGRAPHY SENSOR received FDA 510(k) clearance on 2016-02-10, under 510(k) number K153144.

Who is the listed applicant for TIO-H DIGITAL RADIOGRAPHY SENSOR?

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

What is the FDA product code for TIO-H DIGITAL RADIOGRAPHY SENSOR?

The FDA product code for TIO-H DIGITAL RADIOGRAPHY SENSOR is MUH.

相關臨床試驗

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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。

官方來源

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