BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK

    K Number: K991545 · Decision Jan 19, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    2
    Review Days
    261

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    Basic Information

    Device Name
    WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK
    K Number
    K991545
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Industrielle Entwicklung Medizintechnik Und Vertri
    Date Received
    May 3, 1999
    Decision Date
    January 19, 2000
    Product Code
    DXQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXQ Blood Pressure Cuff

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    Other Clearances by Industrielle Entwicklung Medizintechnik Und Vertri

    K Number Device Name
    K964235 ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL