BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PRINTER, DIGITAL

    K Number: K781115 · Decision Oct 6, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    86
    Applicant Total
    5
    Review Days
    95

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    Basic Information

    Device Name
    PRINTER, DIGITAL
    K Number
    K781115
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.2810
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Output, Inc.
    Date Received
    July 3, 1978
    Decision Date
    October 6, 1978
    Product Code
    DSF
    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
    DSF Recorder, Paper Chart

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    Other Clearances by Output, Inc.

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    K800360 OUTPUT DIGITAL DISPLAY MODULE, MOD. 611
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    K770987 NERVE STIMULATOR, MOLEL NO. FB-800
    K760614 PERIPHERAL NERVE STIMULATOR