BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    STETHOS

    K Number: K963621 · Decision Dec 4, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    153
    Applicant Total
    2
    Review Days
    89

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    Basic Information

    Device Name
    STETHOS
    K Number
    K963621
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Theratechnologies, Inc.
    Date Received
    September 6, 1996
    Decision Date
    December 4, 1996
    Product Code
    DQD
    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
    DQD Stethoscope, Electronic

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    Other Clearances by Theratechnologies, Inc.

    K Number Device Name
    K981171 ERADIC-ALL