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 a medical device manufactured by Fotona D.O.O.. It received FDA 510(k) clearance on 2020-03-27 under approval 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. It is manufactured by Fotona D.O.O.. The 510(k) number is K193656.
When was SkyPulse approved by the FDA?
SkyPulse received FDA 510(k) clearance on 2020-03-27, under approval number K193656.
What company makes SkyPulse?
SkyPulse is manufactured by Fotona D.O.O..
What is the FDA product code for SkyPulse?
The FDA product code for SkyPulse 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.