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

    BEAR 7 VENTILATOR

    K Number: K912619 · Decision Jun 11, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    28
    Review Days
    364

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    Basic Information

    Device Name
    BEAR 7 VENTILATOR
    K Number
    K912619
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bear Medical Systems, Inc.
    Date Received
    June 13, 1991
    Decision Date
    June 11, 1992
    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
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    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
    K881335 BEAR 3 VENTILATOR
    K872660 BEAR NVM-1
    K873634 BEAR VH-820 HUMIDIFIER
    Search all 28 clearances from Bear Medical Systems, Inc. →