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510(k) Data Aggregation

    K Number
    K013478
    Device Name
    DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM
    Manufacturer
    PULSE METRIC, INC.
    Date Cleared
    2002-01-10

    (83 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    PULSE METRIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DynaPulse 5200A Pathway is indicated for trained medical professionals to operate on patients at clinical settings to collect and measure blood pressure and pulse rate information. In addition, the DynaPulse DPS200A Pathway is indicated for patients at home who are capable and willing to selfadministrate this device upon prescription of their healthcare provider. The DP5200A monitor must be connected to an IBM PC-compatible computer that is concurrently running DP5200A Pathway PC Software. The device does not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
    Device Description
    Noninvasive blood pressure measurement system.
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    K Number
    K013358
    Device Name
    DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM
    Manufacturer
    PULSE METRIC, INC.
    Date Cleared
    2001-12-13

    (64 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    PULSE METRIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DynaPulse 5000A Mini (ABP) is indicated for trained medical rofessionals to operate on a patient at clinical settings to collect and measure blood pressure, pulse rate and pressure waveform information, including ambulatory monitoring.
    Device Description
    Not Found
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    K Number
    K012498
    Device Name
    DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM
    Manufacturer
    PULSE METRIC, INC.
    Date Cleared
    2001-11-01

    (90 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    PULSE METRIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DynaPulse 500G is indicated for trained medical professionals to operate on partient at clinical settings to collect and measure blood pressure, pulser and pressure waveform information. In addition, the Dyllar uise 2000 is marcated to purchase week on the device does not send any administrate this device upon present and experience are required to check and interpret the information delivered.
    Device Description
    DynaPulse Model DP500G Non-Invasive Blood Pressure Monitor
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