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

    AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED

    K Number: K915890 · Decision Jun 24, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    12
    Review Days
    183

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    Basic Information

    Device Name
    AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED
    K Number
    K915890
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pegasus Research Corp.
    Date Received
    December 24, 1991
    Decision Date
    June 24, 1992
    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 Pegasus Research Corp.

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    K946057 AQUALARM MOISTURE SENSOR MODEL P85000
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    K903489 THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000
    K893942 THERA-MIST(TM) NEBULIZER, MODEL 30000
    K894000 THERA-MIST HUMIDIFIER
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