FDA 510(k)

Hakon, Hakon Smart

K号: K231901 · 2023-09-28

申请人Medical San Indústria DE Equipamentos Médicos Ltda.

决定日期2023-09-28

产品代码GEX

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决定实质等同

器械摘要

Hakon, Hakon Smart 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 2023-09-28 under 510(k) number K231901. 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 Hakon, Hakon Smart?

Hakon, Hakon Smart is a medical device that received FDA 510(k) clearance on 2023-09-28. The listed applicant is Medical San Indústria DE Equipamentos Médicos Ltda.. The 510(k) number is K231901.

When did Hakon, Hakon Smart receive FDA 510(k) clearance?

Hakon, Hakon Smart received FDA 510(k) clearance on 2023-09-28, under 510(k) number K231901.

Who is the listed applicant for Hakon, Hakon Smart?

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 Hakon, Hakon Smart?

The FDA product code for Hakon, Hakon Smart is GEX. This falls under the Gastroenterology category.

列明Medical San Indústria DE Equipamentos Médicos Ltda.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。

K241771Liftendo; Liftendo 2.0

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