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

    SSH-160A ULTRASONIC PULSED ECHO IMAGING SYSTEM

    K Number: K875266 · Decision Apr 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    47
    Applicant Total
    54
    Review Days
    129

    Basic Information

    Device Name
    SSH-160A ULTRASONIC PULSED ECHO IMAGING SYSTEM
    K Number
    K875266
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    TOSHIBA MEDICAL SYSTEMS
    Date Received
    December 22, 1987
    Decision Date
    April 29, 1988
    Product Code
    DPT
    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
    DPT Probe, Blood-Flow, Extravascular

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