FDA 510(k)

Liftendo；Liftendo 2.0

K 號：K241771 · 2024-09-16

申請人Medical San Indústria DE Equipamentos Médicos Ltda.

決定日期2024-09-16

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

Liftendo; Liftendo 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Medical San Indústria DE Equipamentos Médicos Ltda.. It received FDA 510(k) clearance on 2024-09-16 under 510(k) number K241771. 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 Liftendo; Liftendo 2.0?

Liftendo; Liftendo 2.0 is a medical device that received FDA 510(k) clearance on 2024-09-16. The listed applicant is Medical San Indústria DE Equipamentos Médicos Ltda.. The 510(k) number is K241771.

When did Liftendo; Liftendo 2.0 receive FDA 510(k) clearance?

Liftendo; Liftendo 2.0 received FDA 510(k) clearance on 2024-09-16, under 510(k) number K241771.

Who is the listed applicant for Liftendo; Liftendo 2.0?

The FDA 510(k) record lists Medical San Indústria DE Equipamentos Médicos Ltda. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Liftendo; Liftendo 2.0?

The FDA product code for Liftendo; Liftendo 2.0 is GEX. This falls under the Gastroenterology category.

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