FDA 510(k)

LeafPure-Echo (LM-LPNdA)

K 號：K253219 · 2025-11-25

申請人Shenzhen Leaflife Technology Co., Ltd.

決定日期2025-11-25

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

LeafPure-Echo (LM-LPNdA) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Leaflife Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-11-25 under 510(k) number K253219. 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 LeafPure-Echo (LM-LPNdA)?

LeafPure-Echo (LM-LPNdA) is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is Shenzhen Leaflife Technology Co., Ltd.. The 510(k) number is K253219.

When did LeafPure-Echo (LM-LPNdA) receive FDA 510(k) clearance?

LeafPure-Echo (LM-LPNdA) received FDA 510(k) clearance on 2025-11-25, under 510(k) number K253219.

Who is the listed applicant for LeafPure-Echo (LM-LPNdA)?

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

What is the FDA product code for LeafPure-Echo (LM-LPNdA)?

The FDA product code for LeafPure-Echo (LM-LPNdA) is GEX. This falls under the Gastroenterology category.

其他以 Shenzhen Leaflife Technology Co., Ltd. 為申請人之記錄

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