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510(k) Data Aggregation

    K Number
    K992857
    Device Name
    LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070
    Manufacturer
    ROCKY MOUNTAIN RESEARCH, INC.
    Date Cleared
    1999-11-10

    (77 days)

    Product Code
    DTW
    Regulation Number
    870.4340
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROCKY MOUNTAIN RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LevelSens is an accessory safety device which monitors blood or saline levels in a reservoir and sounds an alarm when the level falls below a predetermined level. It is currently configured for intended use with either Rigid Polycarbonate or Flexible Polyvinyl chloride (PVC) reservoirs.
    Device Description
    Not Found
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    K Number
    K961364
    Device Name
    AUTOMATIC TUBING CLAMP SYSTEM (ATC)
    Manufacturer
    ROCKY MOUNTAIN RESEARCH, INC.
    Date Cleared
    1996-10-31

    (205 days)

    Product Code
    KRL
    Regulation Number
    870.4205
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROCKY MOUNTAIN RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961598
    Device Name
    ELS AUTOMATIC TUBING CLAMP SYSTEM
    Manufacturer
    ROCKY MOUNTAIN RESEARCH, INC.
    Date Cleared
    1996-10-29

    (203 days)

    Product Code
    KRL
    Regulation Number
    870.4205
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROCKY MOUNTAIN RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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