585
K-Number: K172198 · 2017-10-17
ApplicantQuanta System Spa
Decision Date2017-10-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
585 is a medical device manufactured by Quanta System Spa. It received FDA 510(k) clearance on 2017-10-17 under approval number K172198. 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 585?
585 is a medical device that received FDA 510(k) clearance on 2017-10-17. It is manufactured by Quanta System Spa. The 510(k) number is K172198.
When was 585 approved by the FDA?
585 received FDA 510(k) clearance on 2017-10-17, under approval number K172198.
What company makes 585?
585 is manufactured by Quanta System Spa.
What is the FDA product code for 585?
The FDA product code for 585 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.