FDA 510(k)

SOLAR GI SYSTEM

K-Number: K031084 · 2004-03-19

ApplicantMedical Measurement Systems B.V.

Decision Date2004-03-19

Product CodeFFX

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SOLAR GI SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Measurement Systems B.V.. It received FDA 510(k) clearance on 2004-03-19 under 510(k) number K031084. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLAR GI SYSTEM?

SOLAR GI SYSTEM is a medical device that received FDA 510(k) clearance on 2004-03-19. The listed applicant is Medical Measurement Systems B.V.. The 510(k) number is K031084.

When did SOLAR GI SYSTEM receive FDA 510(k) clearance?

SOLAR GI SYSTEM received FDA 510(k) clearance on 2004-03-19, under 510(k) number K031084.

Who is the listed applicant for SOLAR GI SYSTEM?

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

What is the FDA product code for SOLAR GI SYSTEM?

The FDA product code for SOLAR GI SYSTEM is FFX.

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Other records listing Medical Measurement Systems B.V. as applicant

K121014SOLAR GI K071094MODIFICATION TO SOLAR GI K060166OHMEGA K052338SOLAR GI K050993MMS VIDEO OPTION K031930HIGH SPEED EMG MODULE

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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.