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

    BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX

    K Number: K982241 · Decision Nov 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    194
    Applicant Total
    2
    Review Days
    158

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    Basic Information

    Device Name
    BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX
    K Number
    K982241
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5830
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Duxbury Scientific, Inc.
    Date Received
    June 25, 1998
    Decision Date
    November 30, 1998
    Product Code
    CAC
    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
    CAC Apparatus, Autotransfusion

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    Other Clearances by Duxbury Scientific, Inc.

    K Number Device Name
    K951592 BETATRANS I AND II