FDA 510(k)

新時代

K 號：K182604 · 2018-11-14

決定日期2018-11-14

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

New Era is the device name listed in this FDA 510(k) record. The listed applicant is Step UP Skin Laser, LLC. It received FDA 510(k) clearance on 2018-11-14 under 510(k) number K182604. 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 New Era?

New Era is a medical device that received FDA 510(k) clearance on 2018-11-14. The listed applicant is Step UP Skin Laser, LLC. The 510(k) number is K182604.

When did New Era receive FDA 510(k) clearance?

New Era received FDA 510(k) clearance on 2018-11-14, under 510(k) number K182604.

Who is the listed applicant for New Era?

The FDA 510(k) record lists Step UP Skin Laser, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for New Era?

The FDA product code for New Era is GEX. This falls under the Gastroenterology category.

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官方來源

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