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

    INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR

    K Number: K800179 · Decision Feb 11, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    13

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    Basic Information

    Device Name
    INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR
    K Number
    K800179
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1270
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Sphygmetrics, Inc.
    Date Received
    January 29, 1980
    Decision Date
    February 11, 1980
    Product Code
    DXW
    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
    DXW System, Phonocatheter, Intracavitary

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