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FDA 510(k)

XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro

K-Number: K182088 · 2018-10-31

ApplicantFotona D.O.O.
Decision Date2018-10-31
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro 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 2018-10-31 under 510(k) number K182088. 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 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro?

XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro is a medical device that received FDA 510(k) clearance on 2018-10-31. The listed applicant is Fotona D.O.O.. The 510(k) number is K182088.

When did XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro receive FDA 510(k) clearance?

XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro received FDA 510(k) clearance on 2018-10-31, under 510(k) number K182088.

Who is the listed applicant for XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro?

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 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro?

The FDA product code for XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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