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FDA 510(k)

SOLAR GI

K-Number: K121014 · 2012-08-01

ApplicantMedical Measurement Systems B.V.
Decision Date2012-08-01
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SOLAR GI 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 2012-08-01 under 510(k) number K121014. 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?

SOLAR GI is a medical device that received FDA 510(k) clearance on 2012-08-01. The listed applicant is Medical Measurement Systems B.V.. The 510(k) number is K121014.

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

SOLAR GI received FDA 510(k) clearance on 2012-08-01, under 510(k) number K121014.

Who is the listed applicant for SOLAR GI?

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?

The FDA product code for SOLAR GI is FFX.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K071094MODIFICATION TO SOLAR GIK060166OHMEGAK052338SOLAR GIK050993MMS VIDEO OPTIONK031084SOLAR GI SYSTEMK031930HIGH SPEED EMG MODULE

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Related Devices (Code: FFX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLCK240007Solar Compact (G4-1)Laborie Medical Technologies, Corp.K231861EndoflipTM 300 SystemCovidien, LLCK223705EndoflipTM 300Covidien, LLCK222000Transit-PelletsMedifactia ABK201106IntraMarX 3D Radiopaque MarkerAnx Robotica Corp

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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