Search Filters

Search Results

Found 7 results

510(k) Data Aggregation

    K Number
    K121014
    Device Name
    SOLAR GI
    Manufacturer
    MEDICAL MEASUREMENT SYSTEMS,B.V.
    Date Cleared
    2012-08-01

    (120 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL MEASUREMENT SYSTEMS,B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MPP Plus is an accessory device to be used with the MMS Solar GI system for intraluminal studies of the gastro-intestinal tract (Pharynx, esophagus, stomach, duodenum, Sphincter of Oddi, small bowel, colon, and anorectal area including rectum) to perfuse demineralized or distilled water through the lumen of a multi-lumen catheter to measure pressures. The perfusion pump can also be used for automated balloon filling (for anorectal manometry studies). The filling lumen of the catheter can be connected to the perfusion pump. Designated catheters and accessories are required for measurement in each specific area.
    Device Description
    Not Found
    Ask a Question
    K Number
    K071094
    Device Name
    MODIFICATION TO SOLAR GI
    Manufacturer
    MEDICAL MEASUREMENT SYSTEMS,B.V.
    Date Cleared
    2007-08-13

    (117 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL MEASUREMENT SYSTEMS,B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Solar Perfusion Pump is an accessory device to be used with the MMS Solar GI system for intraluminal studies of the gastro-intestinal tract (Pharynx, esophagus, stomach, duodenum, Sphincter of Oddi, small bowel, colon, and anorectal area including rectum) to perfuse demineralized or distilled water through the lumen of a multi-lumen catheter to measure pressures. Designated catheters and accessories are required for measurement in each specific area.
    Device Description
    Not Found
    Ask a Question
    K Number
    K060166
    Device Name
    OHMEGA
    Manufacturer
    MEDICAL MEASUREMENT SYSTEMS,B.V.
    Date Cleared
    2006-04-21

    (88 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL MEASUREMENT SYSTEMS,B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ohmega system is intended to record, store, view and analyse pH, impedance, pressure and various auxiliary input data in the gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphincter of oddi, small bowel, colon and anorectal area including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area.
    Device Description
    Not Found
    Ask a Question
    K Number
    K052338
    Device Name
    SOLAR GI
    Manufacturer
    MEDICAL MEASUREMENT SYSTEMS,B.V.
    Date Cleared
    2005-12-15

    (111 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL MEASUREMENT SYSTEMS,B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Solar GI system is intended to record, store, view and analyse pressure, EMG, swallow and respiration and various auxiliary input device data on-line anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphincter of oddi, small bowel, colon and anorectal area including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area.
    Device Description
    Not Found
    Ask a Question
    K Number
    K050993
    Device Name
    MMS VIDEO OPTION
    Manufacturer
    MEDICAL MEASUREMENT SYSTEMS,B.V.
    Date Cleared
    2005-05-26

    (37 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL MEASUREMENT SYSTEMS,B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MMS Video option is intended to acquire, view, record, process, print, archive and retrieve video images such as of gastroenterology and urology procedures.
    Device Description
    Not Found
    Ask a Question
    K Number
    K031084
    Device Name
    SOLAR GI SYSTEM
    Manufacturer
    MEDICAL MEASUREMENT SYSTEMS,B.V.
    Date Cleared
    2004-03-19

    (350 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL MEASUREMENT SYSTEMS,B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Solar GI system is intended to record, store, view and analyse pressure, EMG, swallow and respiration and various auxiliary input device data on-line anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphirycter of oddi, small bowel, colon and anorectal area including rectum and pelvic flor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area.
    Device Description
    Not Found
    Ask a Question
    K Number
    K031930
    Device Name
    HIGH SPEED EMG MODULE
    Manufacturer
    MEDICAL MEASUREMENT SYSTEMS,B.V.
    Date Cleared
    2004-03-03

    (254 days)

    Product Code
    GWF, FEN, JXE
    Regulation Number
    882.1870
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL MEASUREMENT SYSTEMS,B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Solar Neuro Module is indicated for electro-physiological testing of the pelvic organs including motor nerve conduction, sacral reflex and free-run EMG tests.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1