ECHOLASER X4
K-Number: K181510 · 2018-09-04
ApplicantEl.En Electronic Engineering Spa
Decision Date2018-09-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
ECHOLASER X4 is a medical device manufactured by El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2018-09-04 under approval number K181510. 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 ECHOLASER X4?
ECHOLASER X4 is a medical device that received FDA 510(k) clearance on 2018-09-04. It is manufactured by El.En Electronic Engineering Spa. The 510(k) number is K181510.
When was ECHOLASER X4 approved by the FDA?
ECHOLASER X4 received FDA 510(k) clearance on 2018-09-04, under approval number K181510.
What company makes ECHOLASER X4?
ECHOLASER X4 is manufactured by El.En Electronic Engineering Spa.
What is the FDA product code for ECHOLASER X4?
The FDA product code for ECHOLASER X4 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.