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FDA 510(k)

VITRA MULTISPOT

K-Number: K122251 · 2013-01-24

ApplicantQuantel Medical
Decision Date2013-01-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VITRA MULTISPOT is the device name listed in this FDA 510(k) record. The listed applicant is Quantel Medical. It received FDA 510(k) clearance on 2013-01-24 under 510(k) number K122251. 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 VITRA MULTISPOT?

VITRA MULTISPOT is a medical device that received FDA 510(k) clearance on 2013-01-24. The listed applicant is Quantel Medical. The 510(k) number is K122251.

When did VITRA MULTISPOT receive FDA 510(k) clearance?

VITRA MULTISPOT received FDA 510(k) clearance on 2013-01-24, under 510(k) number K122251.

Who is the listed applicant for VITRA MULTISPOT?

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

What is the FDA product code for VITRA MULTISPOT?

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

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Other records listing Quantel Medical as applicant

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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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