Chrome
K-Number: K202503 · 2020-11-18
ApplicantQuanta System Spa
Decision Date2020-11-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Chrome is a medical device manufactured by Quanta System Spa. It received FDA 510(k) clearance on 2020-11-18 under approval number K202503. 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 Chrome?
Chrome is a medical device that received FDA 510(k) clearance on 2020-11-18. It is manufactured by Quanta System Spa. The 510(k) number is K202503.
When was Chrome approved by the FDA?
Chrome received FDA 510(k) clearance on 2020-11-18, under approval number K202503.
What company makes Chrome?
Chrome is manufactured by Quanta System Spa.
What is the FDA product code for Chrome?
The FDA product code for Chrome 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.