Rosso
K-Number: K211228 · 2022-02-02
ApplicantQuanta System Spa
Decision Date2022-02-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Rosso is a medical device manufactured by Quanta System Spa. It received FDA 510(k) clearance on 2022-02-02 under approval number K211228. 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 Rosso?
Rosso is a medical device that received FDA 510(k) clearance on 2022-02-02. It is manufactured by Quanta System Spa. The 510(k) number is K211228.
When was Rosso approved by the FDA?
Rosso received FDA 510(k) clearance on 2022-02-02, under approval number K211228.
What company makes Rosso?
Rosso is manufactured by Quanta System Spa.
What is the FDA product code for Rosso?
The FDA product code for Rosso 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.