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FDA 510(k)

SkyPulse

K-Number: K193656 · 2020-03-27

ApplicantFotona D.O.O.
Decision Date2020-03-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SkyPulse 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 2020-03-27 under 510(k) number K193656. 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 SkyPulse?

SkyPulse is a medical device that received FDA 510(k) clearance on 2020-03-27. The listed applicant is Fotona D.O.O.. The 510(k) number is K193656.

When did SkyPulse receive FDA 510(k) clearance?

SkyPulse received FDA 510(k) clearance on 2020-03-27, under 510(k) number K193656.

Who is the listed applicant for SkyPulse?

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 SkyPulse?

The FDA product code for SkyPulse is GEX. This falls under the Gastroenterology category.

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

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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