BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇿 New Zealand

    MR630 ENHANCED DUAL SERVO HEATER HUMIDIFIER

    K Number: K872138 · Decision Oct 7, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    216
    Applicant Total
    12
    Review Days
    126

    Basic Information

    Device Name
    MR630 ENHANCED DUAL SERVO HEATER HUMIDIFIER
    K Number
    K872138
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    FISHER & PAYKEL ALLIED PRODUCTS LTD.
    Date Received
    June 3, 1987
    Decision Date
    October 7, 1987
    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 FISHER & PAYKEL ALLIED PRODUCTS LTD.

    K Number Device Name
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    K870055 MR590 DUAL HOSE HEATER POWER PACK
    K862923 MR620 DUAL SERVO HEATED ANAESTHESIA HUMIDIFIER
    K852962 PERIPHERAL NERVE STIMULATOR MODEL A400
    K851879 HEATED RESPIRATORY HUMIDIFIER
    K850647 HEATED RESPIRATORY HUMIFIFIER MR440
    K843903 HEATED RESPIRATORY HUMIDIFIER MR428
    K832928 SERVO HEATED RESPIRATORY HUMIDIFIER
    Search all 12 clearances from FISHER & PAYKEL ALLIED PRODUCTS LTD. →