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

    ARISTO ESOPHAGEAL STETHOSCOPE

    K Number: K961060 · Decision Jun 19, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    4
    Review Days
    93

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    Basic Information

    Device Name
    ARISTO ESOPHAGEAL STETHOSCOPE
    K Number
    K961060
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1920
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aristo Medical Products, Inc.
    Date Received
    March 18, 1996
    Decision Date
    June 19, 1996
    Product Code
    BZT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BZT Stethoscope, Esophageal, With Electrical Conductors

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    Other Clearances by Aristo Medical Products, Inc.

    K Number Device Name
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    K953817 ARISTO MEDICAL MODEL 2101 PATIENT MONITOR
    K920966 SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT)