Hakon, Hakon Smart

Hakon, Hakon Smart is a medical device manufactured by Medical San Indústria DE Equipamentos Médicos Ltda.. It received FDA 510(k) clearance on 2023-09-28 under approval 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.