DEKA MOTUS AX
K-Number: K162886 · 2017-06-19
ApplicantEl.En Electronic Engineering Spa
Decision Date2017-06-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
DEKA MOTUS AX is a medical device manufactured by El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2017-06-19 under approval number K162886. 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 MOTUS AX?
DEKA MOTUS AX is a medical device that received FDA 510(k) clearance on 2017-06-19. It is manufactured by El.En Electronic Engineering Spa. The 510(k) number is K162886.
When was DEKA MOTUS AX approved by the FDA?
DEKA MOTUS AX received FDA 510(k) clearance on 2017-06-19, under approval number K162886.
What company makes DEKA MOTUS AX?
DEKA MOTUS AX is manufactured by El.En Electronic Engineering Spa.
What is the FDA product code for DEKA MOTUS AX?
The FDA product code for DEKA MOTUS AX 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.