FDA 510(k)

Lucid Q-PTP / HWA 55

K 號：K161670 · 2016-11-02

決定日期2016-11-02

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

Lucid Q-PTP / HWA 55 is the device name listed in this FDA 510(k) record. The listed applicant is Bison Medical Co, Ltd.. It received FDA 510(k) clearance on 2016-11-02 under 510(k) number K161670. 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 Lucid Q-PTP / HWA 55?

Lucid Q-PTP / HWA 55 is a medical device that received FDA 510(k) clearance on 2016-11-02. The listed applicant is Bison Medical Co, Ltd.. The 510(k) number is K161670.

When did Lucid Q-PTP / HWA 55 receive FDA 510(k) clearance?

Lucid Q-PTP / HWA 55 received FDA 510(k) clearance on 2016-11-02, under 510(k) number K161670.

Who is the listed applicant for Lucid Q-PTP / HWA 55?

The FDA 510(k) record lists Bison Medical Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lucid Q-PTP / HWA 55?

The FDA product code for Lucid Q-PTP / HWA 55 is GEX. This falls under the Gastroenterology category.

其他以 Bison Medical Co, Ltd. 為申請人之記錄

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K160227ACCENTO / HWA 雙/單激光

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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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