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

    CASSETTE TAPE REPLAY SYSTEM

    K Number: K870554 · Decision Mar 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    193
    Applicant Total
    1
    Review Days
    41

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    Basic Information

    Device Name
    CASSETTE TAPE REPLAY SYSTEM
    K Number
    K870554
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Research Instrumentation Associates, Inc.
    Date Received
    February 10, 1987
    Decision Date
    March 23, 1987
    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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