FDA 510(k)

BBX1, BBX2, BBX1MO, BBX1MC

K号: K142846 · 2016-09-08

决定日期2016-09-08

产品代码DZE

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决定实质等同

器械摘要

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.

常见问题

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.

官方来源

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器械摘要

常见问题

相关器械（代码：DZE）

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