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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Fotona D.O.O.. It received FDA 510(k) clearance on 2022-09-08 under 510(k) 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. The listed applicant is Fotona D.O.O.. The 510(k) number is K213267.

When did Dynamis Pro Family receive FDA 510(k) clearance?

Dynamis Pro Family received FDA 510(k) clearance on 2022-09-08, under 510(k) number K213267.

Who is the listed applicant for Dynamis Pro Family?

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

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.

Other records listing Fotona D.O.O. as applicant

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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.

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