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

    ELECTRONIC DIGITAL SPHYGMOMANOMETER

    K Number: K820300 · Decision Mar 25, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    5
    Review Days
    49

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    Basic Information

    Device Name
    ELECTRONIC DIGITAL SPHYGMOMANOMETER
    K Number
    K820300
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Copal, Inc.
    Date Received
    February 4, 1982
    Decision Date
    March 25, 1982
    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 Copal, Inc.

    K Number Device Name
    K832721 DIGITAL SPHYGMOMANOMETER UA-231
    K832723 DIGITAL SPHGMOMANOMETER UA-271
    K832722 DIGITAL SPHYGMOMANOMETER UA-251
    K832724 ACTIMETER UB-103