DEKA SMARTXIDE ULTRASPEED
K-Number: K172363 · 2017-11-17
ApplicantEl.En Electronic Engineering Spa
Decision Date2017-11-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
DEKA SMARTXIDE ULTRASPEED is a medical device manufactured by El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2017-11-17 under approval number K172363. 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 DEKA SMARTXIDE ULTRASPEED?
DEKA SMARTXIDE ULTRASPEED is a medical device that received FDA 510(k) clearance on 2017-11-17. It is manufactured by El.En Electronic Engineering Spa. The 510(k) number is K172363.
When was DEKA SMARTXIDE ULTRASPEED approved by the FDA?
DEKA SMARTXIDE ULTRASPEED received FDA 510(k) clearance on 2017-11-17, under approval number K172363.
What company makes DEKA SMARTXIDE ULTRASPEED?
DEKA SMARTXIDE ULTRASPEED is manufactured by El.En Electronic Engineering Spa.
What is the FDA product code for DEKA SMARTXIDE ULTRASPEED?
The FDA product code for DEKA SMARTXIDE ULTRASPEED 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.