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

    EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION

    K Number: K000237 · Decision Jun 13, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    2
    Review Days
    138

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    Basic Information

    Device Name
    EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION
    K Number
    K000237
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cybercare, Inc.
    Date Received
    January 27, 2000
    Decision Date
    June 13, 2000
    Product Code
    DXN
    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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    Other Clearances by Cybercare, Inc.

    K Number Device Name
    K002388 EHC500 DESKTOP PATIENT STATION, MODEL EHC500