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

    SPECTRUM POLYCORD I RECORDER SYSTEM

    K Number: K862776 · Decision Aug 18, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    193
    Applicant Total
    2
    Review Days
    27

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    Basic Information

    Device Name
    SPECTRUM POLYCORD I RECORDER SYSTEM
    K Number
    K862776
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cardionics, Inc.
    Date Received
    July 22, 1986
    Decision Date
    August 18, 1986
    Product Code
    DSH
    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
    DSH Recorder, Magnetic Tape, Medical

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    Other Clearances by Cardionics, Inc.

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