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510(k) Data Aggregation

    K Number
    K071960
    Device Name
    MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05
    Manufacturer
    Date Cleared
    2007-08-03

    (18 days)

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

    MEDITECH KFT.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Meditech ABPM-05 Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring.
    Device Description
    Meditech ABPM-05 Ambulatory Blood Pressure Monitor
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    K Number
    K051149
    Device Name
    MEDITECH MODEL ABPM-04
    Manufacturer
    Date Cleared
    2005-11-18

    (198 days)

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

    MEDITECH KFT.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Meditech ABPM-04 device automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring.
    Device Description
    The Meditech ABPM-04 device automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software.
    Ask a Question

    Ask a specific question about this device

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