FDA 510(k)

Eneka Selectif

K号: K241656 · 2024-08-12

决定日期2024-08-12

产品代码GEX

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决定实质等同

器械摘要

Eneka Selectif is the device name listed in this FDA 510(k) record. The listed applicant is Termosalud. It received FDA 510(k) clearance on 2024-08-12 under 510(k) number K241656. 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.

常见问题

What is the Eneka Selectif?

Eneka Selectif is a medical device that received FDA 510(k) clearance on 2024-08-12. The listed applicant is Termosalud. The 510(k) number is K241656.

When did Eneka Selectif receive FDA 510(k) clearance?

Eneka Selectif received FDA 510(k) clearance on 2024-08-12, under 510(k) number K241656.

Who is the listed applicant for Eneka Selectif?

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

What is the FDA product code for Eneka Selectif?

The FDA product code for Eneka Selectif is GEX. This falls under the Gastroenterology category.

列明Termosalud为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K243488VMAT PRO K230659Zionic 美容设备 K230412Symmed Elite 美容 K223680Eneka Pro

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