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

    BEAR JET 150 VENTILATOR

    K Number: K830165 · Decision Apr 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    7
    Applicant Total
    28
    Review Days
    84

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    Basic Information

    Device Name
    BEAR JET 150 VENTILATOR
    K Number
    K830165
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6100
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Bear Medical Systems, Inc.
    Date Received
    January 18, 1983
    Decision Date
    April 12, 1983
    Product Code
    FLI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FLI Cabinet, Ethylene-Oxide Gas Aerator

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