FDA 510(k)

BBX1, BBX2, BBX1MO, BBX1MC

K 號：K142846 · 2016-09-08

決定日期2016-09-08

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

BBX1, BBX2, BBX1MO, BBX1MC is the device name listed in this FDA 510(k) record. The listed applicant is Globaldental, Inc.. It received FDA 510(k) clearance on 2016-09-08 under 510(k) number K142846. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BBX1, BBX2, BBX1MO, BBX1MC?

BBX1, BBX2, BBX1MO, BBX1MC is a medical device that received FDA 510(k) clearance on 2016-09-08. The listed applicant is Globaldental, Inc.. The 510(k) number is K142846.

When did BBX1, BBX2, BBX1MO, BBX1MC receive FDA 510(k) clearance?

BBX1, BBX2, BBX1MO, BBX1MC received FDA 510(k) clearance on 2016-09-08, under 510(k) number K142846.

Who is the listed applicant for BBX1, BBX2, BBX1MO, BBX1MC?

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

What is the FDA product code for BBX1, BBX2, BBX1MO, BBX1MC?

The FDA product code for BBX1, BBX2, BBX1MO, BBX1MC is DZE.

相關器械（代碼：DZE）

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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