SUPER VELOCE
K-Number: K241699 · 2024-08-13
ApplicantIlooda Co,., Ltd.
Decision Date2024-08-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SUPER VELOCE is a medical device manufactured by Ilooda Co,., Ltd.. It received FDA 510(k) clearance on 2024-08-13 under approval number K241699. 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.
Frequently Asked Questions
What is the SUPER VELOCE?
SUPER VELOCE is a medical device that received FDA 510(k) clearance on 2024-08-13. It is manufactured by Ilooda Co,., Ltd.. The 510(k) number is K241699.
When was SUPER VELOCE approved by the FDA?
SUPER VELOCE received FDA 510(k) clearance on 2024-08-13, under approval number K241699.
What company makes SUPER VELOCE?
SUPER VELOCE is manufactured by Ilooda Co,., Ltd..
What is the FDA product code for SUPER VELOCE?
The FDA product code for SUPER VELOCE is GEX. This falls under the Gastroenterology category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.