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

    BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY

    K Number: K896315 · Decision Jan 22, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    28
    Review Days
    82

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    Basic Information

    Device Name
    BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY
    K Number
    K896315
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Bear Medical Systems, Inc.
    Date Received
    November 1, 1989
    Decision Date
    January 22, 1990
    Product Code
    BTT
    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
    BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

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    Other Clearances by Bear Medical Systems, Inc.

    K Number Device Name
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    K912619 BEAR 7 VENTILATOR
    K900637 BEAR CEM CONTROLLER
    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. →