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FDA 510(k)

MDK MULTI-APPLICATIONS PLATFORM

K-Number: K130256 · 2013-07-02

ApplicantQuanta System Spa
Decision Date2013-07-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MDK MULTI-APPLICATIONS PLATFORM 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 2013-07-02 under 510(k) number K130256. 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 MDK MULTI-APPLICATIONS PLATFORM?

MDK MULTI-APPLICATIONS PLATFORM is a medical device that received FDA 510(k) clearance on 2013-07-02. The listed applicant is Quanta System Spa. The 510(k) number is K130256.

When did MDK MULTI-APPLICATIONS PLATFORM receive FDA 510(k) clearance?

MDK MULTI-APPLICATIONS PLATFORM received FDA 510(k) clearance on 2013-07-02, under 510(k) number K130256.

Who is the listed applicant for MDK MULTI-APPLICATIONS PLATFORM?

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 MDK MULTI-APPLICATIONS PLATFORM?

The FDA product code for MDK MULTI-APPLICATIONS PLATFORM 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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