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

    STERILE INHALATION WATER TRANSFER SET

    K Number: K882582 · Decision Sep 30, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    29
    Review Days
    100

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    Basic Information

    Device Name
    STERILE INHALATION WATER TRANSFER SET
    K Number
    K882582
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Intertech Resources, Inc.
    Date Received
    June 22, 1988
    Decision Date
    September 30, 1988
    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 Intertech Resources, Inc.

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    K952169 SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC
    K952214 SIMS INTERTECH HYPERINFLATION BAG SYSTEM
    K935036 HEPA FILTERED HEAT AND MOISTURE EXCHANGER
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