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

    TELEPULSE

    K Number: K925040 · Decision Aug 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    10
    Applicant Total
    4
    Review Days
    322

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    Basic Information

    Device Name
    TELEPULSE
    K Number
    K925040
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1760
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biometrix , Ltd.
    Date Received
    October 5, 1992
    Decision Date
    August 23, 1993
    Product Code
    JEH
    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
    JEH Plethysmograph, Volume

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