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

    VAPOR-PHASE HUMIDIFIER SYSTEM

    K Number: K831556 · Decision Jul 19, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    5
    Review Days
    64

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    Basic Information

    Device Name
    VAPOR-PHASE HUMIDIFIER SYSTEM
    K Number
    K831556
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Cygnus Research Corp.
    Date Received
    May 16, 1983
    Decision Date
    July 19, 1983
    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 Cygnus Research Corp.

    K Number Device Name
    K831163 LO-COMP RESERVOIR-RE-1000
    K830923 TEMP-CHECK ADAPTOR, STRAIGHT CONFIGURA
    K830922 TEMP-CHECK ADAPTOR, TEE-CONFIGURATION
    K830921 TEMP-CHECK ADAPTOR, Y-CONFIGURATION