Dynamis Pro Family
K-Number: K213267 · 2022-09-08
ApplicantFotona D.O.O.
Decision Date2022-09-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Dynamis Pro Family is a medical device manufactured by Fotona D.O.O.. It received FDA 510(k) clearance on 2022-09-08 under approval number K213267. 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 Dynamis Pro Family?
Dynamis Pro Family is a medical device that received FDA 510(k) clearance on 2022-09-08. It is manufactured by Fotona D.O.O.. The 510(k) number is K213267.
When was Dynamis Pro Family approved by the FDA?
Dynamis Pro Family received FDA 510(k) clearance on 2022-09-08, under approval number K213267.
What company makes Dynamis Pro Family?
Dynamis Pro Family is manufactured by Fotona D.O.O..
What is the FDA product code for Dynamis Pro Family?
The FDA product code for Dynamis Pro Family 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.