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FDA 510(k)

Rosso

K-Number: K211228 · 2022-02-02

ApplicantQuanta System Spa
Decision Date2022-02-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Rosso is the device name listed in this FDA 510(k) record. The listed applicant is Quanta System Spa. It received FDA 510(k) clearance on 2022-02-02 under 510(k) 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. The listed applicant is Quanta System Spa. The 510(k) number is K211228.

When did Rosso receive FDA 510(k) clearance?

Rosso received FDA 510(k) clearance on 2022-02-02, under 510(k) number K211228.

Who is the listed applicant for Rosso?

The FDA 510(k) record lists Quanta System Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rosso?

The FDA product code for Rosso is GEX. This falls under the Gastroenterology category.

Other records listing Quanta System Spa as applicant

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Related Devices (Code: GEX)

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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.

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