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FDA 510(k)

QUANTA SYSTEM DUOLITE

K-Number: K103539 · 2011-01-20

ApplicantQuanta System Spa
Decision Date2011-01-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

QUANTA SYSTEM DUOLITE 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 2011-01-20 under 510(k) number K103539. 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 QUANTA SYSTEM DUOLITE?

QUANTA SYSTEM DUOLITE is a medical device that received FDA 510(k) clearance on 2011-01-20. The listed applicant is Quanta System Spa. The 510(k) number is K103539.

When did QUANTA SYSTEM DUOLITE receive FDA 510(k) clearance?

QUANTA SYSTEM DUOLITE received FDA 510(k) clearance on 2011-01-20, under 510(k) number K103539.

Who is the listed applicant for QUANTA SYSTEM DUOLITE?

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 QUANTA SYSTEM DUOLITE?

The FDA product code for QUANTA SYSTEM DUOLITE 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.

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