FDA 510(k)

牙科5多二極雷射

K 號：K163638 · 2017-05-15

決定日期2017-05-15

產品代碼GEX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Dental 5 Multi Diode laser is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Med USA, Inc.. It received FDA 510(k) clearance on 2017-05-15 under 510(k) number K163638. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Dental 5 Multi Diode laser?

Dental 5 Multi Diode laser is a medical device that received FDA 510(k) clearance on 2017-05-15. The listed applicant is Bio-Med USA, Inc.. The 510(k) number is K163638.

When did Dental 5 Multi Diode laser receive FDA 510(k) clearance?

Dental 5 Multi Diode laser received FDA 510(k) clearance on 2017-05-15, under 510(k) number K163638.

Who is the listed applicant for Dental 5 Multi Diode laser?

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

What is the FDA product code for Dental 5 Multi Diode laser?

The FDA product code for Dental 5 Multi Diode laser is GEX. This falls under the Gastroenterology category.

其他以 Bio-Med USA, Inc. 為申請人之記錄

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