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

    BEAR 3 VENTILATOR

    K Number: K881335 · Decision Aug 4, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    28
    Review Days
    128

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    Basic Information

    Device Name
    BEAR 3 VENTILATOR
    K Number
    K881335
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Bear Medical Systems, Inc.
    Date Received
    March 29, 1988
    Decision Date
    August 4, 1988
    Product Code
    CBK
    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
    CBK Ventilator, Continuous, Facility Use

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    Other Clearances by Bear Medical Systems, Inc.

    K Number Device Name
    K992788 BEAR CUB 750 PSV
    K983981 BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE
    K912619 BEAR 7 VENTILATOR
    K900637 BEAR CEM CONTROLLER
    K896315 BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY
    K893034 VHS 820 HUMIDIFIER, MODIFICATION
    K890724 MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR
    K882764 BEAR EVC-100 CONTROLLER
    K872660 BEAR NVM-1
    K873634 BEAR VH-820 HUMIDIFIER
    Search all 28 clearances from Bear Medical Systems, Inc. →