FDA 510(k)

多脉冲HoPLUS

K 號：K161257 · 2017-03-31

決定日期2017-03-31

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

MultiPulse HoPLUS is the device name listed in this FDA 510(k) record. The listed applicant is Asclepion Laser Technologies GmbH. It received FDA 510(k) clearance on 2017-03-31 under 510(k) number K161257. 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 MultiPulse HoPLUS?

MultiPulse HoPLUS is a medical device that received FDA 510(k) clearance on 2017-03-31. The listed applicant is Asclepion Laser Technologies GmbH. The 510(k) number is K161257.

When did MultiPulse HoPLUS receive FDA 510(k) clearance?

MultiPulse HoPLUS received FDA 510(k) clearance on 2017-03-31, under 510(k) number K161257.

Who is the listed applicant for MultiPulse HoPLUS?

The FDA 510(k) record lists Asclepion Laser Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MultiPulse HoPLUS?

The FDA product code for MultiPulse HoPLUS is GEX. This falls under the Gastroenterology category.

其他以 Asclepion Laser Technologies GmbH 為申請人之記錄

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