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

    PATIENT CIRCUIT MANIFOLD

    K Number: K781485 · Decision Oct 16, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    9
    Review Days
    49

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    Basic Information

    Device Name
    PATIENT CIRCUIT MANIFOLD
    K Number
    K781485
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Bourns Medical Systems, Inc.
    Date Received
    August 28, 1978
    Decision Date
    October 16, 1978
    Product Code
    CAF
    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
    CAF Nebulizer (Direct Patient Interface)

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    K791186 MODEL BP-2000 TIME-CYCLED VENTILATOR
    K790199 VENTILATOR MODEL BV-300 INFANT
    K781760 HUMIDIFIERS, MODEL:LS-420 AND LS-460
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    K781428 FLEXTUBES:9, 20, 26