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

    OUTPUT DIGITAL DISPLAY MODULE, MODEL 401

    K Number: K780356 · Decision May 31, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    76
    Applicant Total
    5
    Review Days
    86

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    OUTPUT DIGITAL DISPLAY MODULE, MODEL 401
    K Number
    K780356
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1110
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Output, Inc.
    Date Received
    March 6, 1978
    Decision Date
    May 31, 1978
    Product Code
    DSK
    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
    DSK Computer, Blood-Pressure

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DSK), ordered by most recent decision date.

    Endophys Blood Pressure Monitor model BPM-30

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Endophys Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENDOPHYS BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Output, Inc.

    K Number Device Name
    K800360 OUTPUT DIGITAL DISPLAY MODULE, MOD. 611
    K781115 PRINTER, DIGITAL
    K770987 NERVE STIMULATOR, MOLEL NO. FB-800
    K760614 PERIPHERAL NERVE STIMULATOR