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

    E-VAC(TM)

    K Number: K862875 · Decision Nov 3, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    5
    Review Days
    96

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    Basic Information

    Device Name
    E-VAC(TM)
    K Number
    K862875
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Laerdal California, Inc.
    Date Received
    July 30, 1986
    Decision Date
    November 3, 1986
    Product Code
    BTA
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BTA Pump, Portable, Aspiration (Manual Or Powered)

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    Other Clearances by Laerdal California, Inc.

    K Number Device Name
    K941578 STATVAC PORTABLE SUCTION UNIT
    K922842 STYLET AND TRACHEAL LIGHTWAND (STL)
    K843790 TRACHEAL TUBE FIXATION DEVICE
    K832990 STIFNICK IMMOBILIZING COLLAR